TriangleNCT03922100 · OUTCOME
Pharmacokinetic Parameters: Apparent Volume of Distribution (V/F) and Apparent Volume of Distribution at Steady State (Vss/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- L
- Interval / dispersion
- Standard Deviation
- Time frame
- Schedule A: Day 21
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. Therefore, parameters V/F, Vss/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 | 0 |
| Phase 1, Schedule B: 180 mg | 0 |
| Phase 1, Schedule B: 250 mg | 0 |
| Phase 2, Schedule B:360+150 mg | 0 |
Reported measurements
V/F: Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 844 | 32.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 2030 | 39.7 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 1940 | 31.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 2680 | 50.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 1630 | 31.0 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 1070 | 17.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 1770 | 36.0 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 1070 | 0 | Not reported | Not reported | Not reported |
Vss/F: Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 4880 | 21.8 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 9440 | 20.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 8800 | 22.8 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 10900 | 39.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 5810 | 25.8 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 4710 | 37.0 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 8270 | 37.0 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 10500 | 0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 32.5
- value
- 844
- group Id
- OG001
- spread
- 39.7
- value
- 2030
- group Id
- OG002
- spread
- 31.3
- value
- 1940
- group Id
- OG003
- spread
- 50.9
- value
- 2680
- group Id
- OG004
- spread
- 31.0
- value
- 1630
- group Id
- OG005
- spread
- 17.5
- value
- 1070
- group Id
- OG006
- spread
- 36.0
- value
- 1770
- group Id
- OG007
- spread
- 0
- value
- 1070
- title
- V/F: Day 21
- categories
- measurements
- group Id
- OG000
- spread
- 21.8
- value
- 4880
- group Id
- OG001
- spread
- 20.3
- value
- 9440
- group Id
- OG002
- spread
- 22.8
- value
- 8800
- group Id
- OG003
- spread
- 39.4
- value
- 10900
- group Id
- OG004
- spread
- 25.8
- value
- 5810
- group Id
- OG005
- spread
- 37.0
- value
- 4710
- group Id
- OG006
- spread
- 37.0
- value
- 8270
- group Id
- OG007
- spread
- 0
- value
- 10500
- title
- Vss/F: Day 21
- 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
- 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. Therefore, parameters V/F, Vss/F could not be calculated.
- reporting Status
- POSTED
- time Frame
- Schedule A: Day 21
- title
- Pharmacokinetic Parameters: Apparent Volume of Distribution (V/F) and Apparent Volume of Distribution at Steady State (Vss/F)
- type
- SECONDARY
- unit Of Measure
- L
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice