TriangleNCT01943851 · OUTCOME
Part 1: AUC(0-24) and AUC[0-inf] of GSK3529246 (Active Metabolite) Following Single Dose Administration
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Hours*nanograms per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
What was measured
Plasma samples for PK analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Analysis population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Groups in this outcome
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 5 mg QD | 0 |
| Part 1: GSK525762 10 mg QD | 0 |
| Part 1: GSK525762 20 mg QD | 0 |
| Part 1: GSK525762 30 mg QD MM | 5 |
| Part 1: GSK525762 40 mg QD | 0 |
| Part 1: GSK525762 40 mg QD MM | 1 |
| Part 1: GSK525762 60 mg QD AML | 0 |
| Part 1: GSK525762 60 mg QD NHL | 15 |
| Part 1: GSK525762 60 mg QD MM | 2 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 0 |
| Part 1: GSK525762 80 mg QD AML | 0 |
| Part 1: GSK525762 80 mg QD NHL | 6 |
| Part 1: GSK525762 100 mg QD AML | 15 |
| Part 1: GSK525762 120 mg QD AML | 0 |
Reported measurements
AUC(0-24), n=0,0,0,5,0,1,0,15, 2,8,0,0,6,15,0
| Group | Source count |
|---|---|
| Part 1: GSK525762 5 mg QD | 0 |
| Part 1: GSK525762 10 mg QD | 0 |
| Part 1: GSK525762 20 mg QD | 0 |
| Part 1: GSK525762 30 mg QD MM | 5 |
| Part 1: GSK525762 40 mg QD | 0 |
| Part 1: GSK525762 40 mg QD MM | 1 |
| Part 1: GSK525762 60 mg QD AML | 0 |
| Part 1: GSK525762 60 mg QD NHL | 15 |
| Part 1: GSK525762 60 mg QD MM | 2 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 0 |
| Part 1: GSK525762 80 mg QD AML | 0 |
| Part 1: GSK525762 80 mg QD NHL | 6 |
| Part 1: GSK525762 100 mg QD AML | 15 |
| Part 1: GSK525762 120 mg QD AML | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 1368.11 | 31.39 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 1891.48 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 60 mg QD NHL | 3048.33 | 22.85 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 3297.95 | 68.31 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 3174.42 | 40.63 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 3432.89 | 39.76 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 2901.79 | 52.33 | Not reported | Not reported | Not reported |
AUC(0-inf), n=0,0,0,5,0,1,0,10, 2,7,0,0,6,7,0
| Group | Source count |
|---|---|
| Part 1: GSK525762 5 mg QD | 0 |
| Part 1: GSK525762 10 mg QD | 0 |
| Part 1: GSK525762 20 mg QD | 0 |
| Part 1: GSK525762 30 mg QD MM | 5 |
| Part 1: GSK525762 40 mg QD | 0 |
| Part 1: GSK525762 40 mg QD MM | 1 |
| Part 1: GSK525762 60 mg QD AML | 0 |
| Part 1: GSK525762 60 mg QD NHL | 10 |
| Part 1: GSK525762 60 mg QD MM | 2 |
| Part 1: GSK525762 75 mg QD AML | 7 |
| Part 1: GSK525762 80 mg QD | 0 |
| Part 1: GSK525762 80 mg QD AML | 0 |
| Part 1: GSK525762 80 mg QD NHL | 6 |
| Part 1: GSK525762 100 mg QD AML | 7 |
| Part 1: GSK525762 120 mg QD AML | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 1691.75 | 28.96 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 2013.33 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 60 mg QD NHL | 3684.96 | 28.50 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 4499.65 | 72.79 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 4003.48 | 42.09 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 3908.15 | 41.20 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 4714.85 | 48.39 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- spread
- 31.39
- value
- 1368.11
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG005
- spread
- NA
- value
- 1891.48
- group Id
- OG007
- spread
- 22.85
- value
- 3048.33
- group Id
- OG008
- spread
- 68.31
- value
- 3297.95
- group Id
- OG009
- spread
- 40.63
- value
- 3174.42
- group Id
- OG012
- spread
- 39.76
- value
- 3432.89
- group Id
- OG013
- spread
- 52.33
- value
- 2901.79
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- AUC(0-24), n=0,0,0,5,0,1,0,15, 2,8,0,0,6,15,0
- categories
- measurements
- group Id
- OG003
- spread
- 28.96
- value
- 1691.75
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG005
- spread
- NA
- value
- 2013.33
- group Id
- OG007
- spread
- 28.50
- value
- 3684.96
- group Id
- OG008
- spread
- 72.79
- value
- 4499.65
- group Id
- OG009
- spread
- 42.09
- value
- 4003.48
- group Id
- OG012
- spread
- 41.20
- value
- 3908.15
- group Id
- OG013
- spread
- 48.39
- value
- 4714.85
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 7
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- AUC(0-inf), n=0,0,0,5,0,1,0,10, 2,7,0,0,6,7,0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- description
- Plasma samples for PK analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 5 mg QD
- description
- Participants were administered once daily oral dose of 10 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 10 mg QD
- description
- Participants were administered once daily oral dose of 20 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 20 mg QD
- description
- Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
- id
- OG003
- title
- Part 1: GSK525762 30 mg QD MM
- description
- Participants were administered once daily oral dose of 40 mg GSK525762.
- id
- OG004
- title
- Part 1: GSK525762 40 mg QD
- description
- Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
- id
- OG005
- title
- Part 1: GSK525762 40 mg QD MM
- description
- Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG006
- title
- Part 1: GSK525762 60 mg QD AML
- description
- Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG007
- title
- Part 1: GSK525762 60 mg QD NHL
- description
- Participants with MM were administered once daily oral dose of 60 mg GSK525762.
- id
- OG008
- title
- Part 1: GSK525762 60 mg QD MM
- description
- Participants with AML were administered once daily oral dose of 75 mg GSK525762.
- id
- OG009
- title
- Part 1: GSK525762 75 mg QD AML
- description
- Participants were administered once daily oral dose of 80 mg GSK525762.
- id
- OG010
- title
- Part 1: GSK525762 80 mg QD
- description
- Participants with AML were administered once daily oral dose of 80 mg GSK525762.
- id
- OG011
- title
- Part 1: GSK525762 80 mg QD AML
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
- reporting Status
- POSTED
- time Frame
- Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
- title
- Part 1: AUC(0-24) and AUC[0-inf] of GSK3529246 (Active Metabolite) Following Single Dose Administration
- type
- SECONDARY
- unit Of Measure
- Hours*nanograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice