TriangleNCT03922100 · OUTCOME
Pharmacokinetic Parameters: Apparent Plasma Clearance (CL/F) and Apparent Plasma Clearance at Steady State (CLss/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- L/h
- Interval / dispersion
- Standard Deviation
- Time frame
- Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28 CL/F: Evaluation of CL/F for Day 1 of all arms in Schedule A and Schedule B and Day 28 of Schedule B has not been performed
What was measured
Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
Analysis population: Participants evaluable for PK analysis (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile. The half-life of the molecule was many times longer than 24 hours, so it was not possible to estimate it at all for Schedule B due to the 24-hour sampling. This implied that the parameter CL/F could not be calculated
Groups in this outcome
Phase 1, Schedule A: 20 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
Phase 1, Schedule A: 40 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 80 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 120 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 180 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 270 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 300 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 360 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule B: 120 mg
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
Phase 1, Schedule B: 180 mg
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
Phase 1, Schedule B: 250 mg
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
Phase 2, Schedule B:360+150 mg
Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B:360+150 mg | 15 |
Reported measurements
CL/F: Day 1
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B:360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 40 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 80 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 120 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 180 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 270 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 300 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule A: 360 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule B: 120 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule B: 180 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule B: 250 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 2, Schedule B:360+150 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
CL/F: Day 21
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 0 |
| Phase 1, Schedule B: 180 mg | 0 |
| Phase 1, Schedule B: 250 mg | 0 |
| Phase 2, Schedule B:360+150 mg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 7.02 | 53.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 20.4 | 57.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 19.0 | 34.6 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 27.6 | 52.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 21.4 | 46.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 12.1 | 26.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 16.8 | 46.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 4.94 | 0 | Not reported | Not reported | Not reported |
CL/F: Day 28
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 0 |
| Phase 1, Schedule A: 40 mg | 0 |
| Phase 1, Schedule A: 80 mg | 0 |
| Phase 1, Schedule A: 120 mg | 0 |
| Phase 1, Schedule A: 180 mg | 0 |
| Phase 1, Schedule A: 270 mg | 0 |
| Phase 1, Schedule A: 300 mg | 0 |
| Phase 1, Schedule A: 360 mg | 0 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B:360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule B: 120 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule B: 180 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 1, Schedule B: 250 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
| Phase 2, Schedule B:360+150 mg | NA | NA | Not reported | Not reported | The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated |
CLss/F: Day 1
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 2 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 9 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B:360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 399 | 19.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 318 | 32.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 372 | 23.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 434 | 41.6 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 301 | 57.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 264 | 44.7 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 477 | 117 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 502 | 126 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 317 | 89.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 263 | 31.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 359 | 97.1 | Not reported | Not reported | Not reported |
| Phase 2, Schedule B:360+150 mg | 1820 | 45.0 | Not reported | Not reported | Not reported |
CLss/F: Day 21
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 0 |
| Phase 1, Schedule B: 180 mg | 0 |
| Phase 1, Schedule B: 250 mg | 0 |
| Phase 2, Schedule B:360+150 mg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 39.9 | 40.8 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 91.2 | 42.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 85.7 | 26.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 110 | 38.6 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 74.7 | 38.7 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 50.9 | 23.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 77.8 | 38.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 98.2 | 50.4 | Not reported | Not reported | Not reported |
CLss/F: Day 28
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 0 |
| Phase 1, Schedule A: 40 mg | 0 |
| Phase 1, Schedule A: 80 mg | 0 |
| Phase 1, Schedule A: 120 mg | 0 |
| Phase 1, Schedule A: 180 mg | 0 |
| Phase 1, Schedule A: 270 mg | 0 |
| Phase 1, Schedule A: 300 mg | 0 |
| Phase 1, Schedule A: 360 mg | 0 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B:360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule B: 120 mg | 57.4 | 46.8 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 56.3 | 35.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 63.8 | 52.7 | Not reported | Not reported | Not reported |
| Phase 2, Schedule B:360+150 mg | 209 | 117 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG004
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG005
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG007
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG008
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG009
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG010
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG011
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- CL/F: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 53.1
- value
- 7.02
- group Id
- OG001
- spread
- 57.1
- value
- 20.4
- group Id
- OG002
- spread
- 34.6
- value
- 19.0
- group Id
- OG003
- spread
- 52.5
- value
- 27.6
- group Id
- OG004
- spread
- 46.5
- value
- 21.4
- group Id
- OG005
- spread
- 26.3
- value
- 12.1
- group Id
- OG006
- spread
- 46.5
- value
- 16.8
- group Id
- OG007
- spread
- 0
- value
- 4.94
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- CL/F: Day 21
- categories
- measurements
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG008
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG009
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG010
- spread
- NA
- value
- NA
- comment
- The half-life of the molecule was many times longer than 24h so it was not possible to estimate it at all for Schedule B due to the 24h sampling. This implied that the parameter CL/F could not be calculated
- group Id
- OG011
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- CL/F: Day 28
- categories
- measurements
- group Id
- OG000
- spread
- 19.9
- value
- 399
- group Id
- OG001
- spread
- 32.2
- value
- 318
- group Id
- OG002
- spread
- 23.3
- value
- 372
- group Id
- OG003
- spread
- 41.6
- value
- 434
- group Id
- OG004
- spread
- 57.5
- value
- 301
- group Id
- OG005
- spread
- 44.7
- value
- 264
- group Id
- OG006
- spread
- 117
- value
- 477
- group Id
- OG007
- spread
- 126
- value
- 502
- group Id
- OG008
- spread
- 89.3
- value
- 317
- group Id
- OG009
- spread
- 31.4
- value
- 263
- group Id
- OG010
- spread
- 97.1
- value
- 359
- group Id
- OG011
- spread
- 45.0
- value
- 1820
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- CLss/F: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 40.8
- value
- 39.9
- group Id
- OG001
- spread
- 42.5
- value
- 91.2
- group Id
- OG002
- spread
- 26.3
- value
- 85.7
- group Id
- OG003
- spread
- 38.6
- value
- 110
- group Id
- OG004
- spread
- 38.7
- value
- 74.7
- group Id
- OG005
- spread
- 23.1
- value
- 50.9
- group Id
- OG006
- spread
- 38.4
- value
- 77.8
- group Id
- OG007
- spread
- 50.4
- value
- 98.2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- CLss/F: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 46.8
- value
- 57.4
- group Id
- OG009
- spread
- 35.5
- value
- 56.3
- group Id
- OG010
- spread
- 52.7
- value
- 63.8
- group Id
- OG011
- spread
- 117
- value
- 209
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- CLss/F: Day 28
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- description
- Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
- dispersion Type
- Standard Deviation
- groups
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- OG000
- title
- Phase 1, Schedule A: 20 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG001
- title
- Phase 1, Schedule A: 40 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG002
- title
- Phase 1, Schedule A: 80 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG003
- title
- Phase 1, Schedule A: 120 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG004
- title
- Phase 1, Schedule A: 180 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG005
- title
- Phase 1, Schedule A: 270 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG006
- title
- Phase 1, Schedule A: 300 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG007
- title
- Phase 1, Schedule A: 360 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
- id
- OG008
- title
- Phase 1, Schedule B: 120 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
- id
- OG009
- title
- Phase 1, Schedule B: 180 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- OG010
- title
- Phase 1, Schedule B: 250 mg
- description
- Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.
- id
- OG011
- title
- Phase 2, Schedule B:360+150 mg
- param Type
- MEAN
- population Description
- Participants evaluable for PK analysis (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile. The half-life of the molecule was many times longer than 24 hours, so it was not possible to estimate it at all for Schedule B due to the 24-hour sampling. This implied that the parameter CL/F could not be calculated
- reporting Status
- POSTED
- time Frame
- Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28 CL/F: Evaluation of CL/F for Day 1 of all arms in Schedule A and Schedule B and Day 28 of Schedule B has not been performed
- title
- Pharmacokinetic Parameters: Apparent Plasma Clearance (CL/F) and Apparent Plasma Clearance at Steady State (CLss/F)
- type
- SECONDARY
- unit Of Measure
- L/h
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Preserved source evidence · Not medical advice