TriangleNCT01943851 · OUTCOME
Part 1: Cmax and Cmin 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
- Nanograms per milliliter (ng/mL)
- 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 pharmacokinetic (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 | 3 |
| 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 | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 0 |
Reported measurements
Cmax, n=0,0,0,5,0,1, 0,15,3,8,0,0,7,16,0
| 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 | 3 |
| 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 | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 109.45 | 45.38 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 246.12 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 60 mg QD NHL | 239.98 | 26.75 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 361.30 | 54.77 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 251.73 | 49.71 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 325.42 | 47.17 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 201.02 | 56.94 | Not reported | Not reported | Not reported |
Cmin, n=0,0,0,2,0,1, 0,14,3,7,0,0,6,13,0
| 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 | 2 |
| 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 | 14 |
| Part 1: GSK525762 60 mg QD MM | 3 |
| 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 | 13 |
| Part 1: GSK525762 120 mg QD AML | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 2.47 | 4.29 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 66.39 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 60 mg QD NHL | 18.17 | 116.63 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 10.83 | 161.52 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 18.45 | 71.98 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 12.66 | 108.08 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 14.17 | 99.02 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- spread
- 45.38
- value
- 109.45
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG005
- spread
- NA
- value
- 246.12
- group Id
- OG007
- spread
- 26.75
- value
- 239.98
- group Id
- OG008
- spread
- 54.77
- value
- 361.30
- group Id
- OG009
- spread
- 49.71
- value
- 251.73
- group Id
- OG012
- spread
- 47.17
- value
- 325.42
- group Id
- OG013
- spread
- 56.94
- value
- 201.02
- 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
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cmax, n=0,0,0,5,0,1, 0,15,3,8,0,0,7,16,0
- categories
- measurements
- group Id
- OG003
- spread
- 4.29
- value
- 2.47
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG005
- spread
- NA
- value
- 66.39
- group Id
- OG007
- spread
- 116.63
- value
- 18.17
- group Id
- OG008
- spread
- 161.52
- value
- 10.83
- group Id
- OG009
- spread
- 71.98
- value
- 18.45
- group Id
- OG012
- spread
- 108.08
- value
- 12.66
- group Id
- OG013
- spread
- 99.02
- value
- 14.17
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 7
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cmin, n=0,0,0,2,0,1, 0,14,3,7,0,0,6,13,0
- 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
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- description
- Plasma samples for pharmacokinetic (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: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Single Dose Administration
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice