TriangleNCT01943851 · OUTCOME
Part 1: T1/2 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
- MEDIAN
- Unit
- Hour
- Interval / dispersion
- Full Range
- 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. Pharmacokinetic 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. 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 | 11 |
| Part 1: GSK525762 60 mg QD MM | 2 |
| Part 1: GSK525762 75 mg QD AML | 6 |
| 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 9.90 | Not reported | 5.2 | 13.4 | Not reported |
| Part 1: GSK525762 40 mg QD MM | 5.83 | Not reported | NA | NA | Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant. |
| Part 1: GSK525762 60 mg QD NHL | 8.66 | Not reported | 6.7 | 14.1 | Not reported |
| Part 1: GSK525762 60 mg QD MM | 12.72 | Not reported | 11.5 | 13.9 | Not reported |
| Part 1: GSK525762 75 mg QD AML | 8.31 | Not reported | 5.4 | 15.7 | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 7.16 | Not reported | 6.3 | 9.1 | Not reported |
| Part 1: GSK525762 100 mg QD AML | 9.23 | Not reported | 5.1 | 15.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- lower Limit
- 5.2
- upper Limit
- 13.4
- value
- 9.90
- comment
- Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 5.83
- group Id
- OG007
- lower Limit
- 6.7
- upper Limit
- 14.1
- value
- 8.66
- group Id
- OG008
- lower Limit
- 11.5
- upper Limit
- 13.9
- value
- 12.72
- group Id
- OG009
- lower Limit
- 5.4
- upper Limit
- 15.7
- value
- 8.31
- group Id
- OG012
- lower Limit
- 6.3
- upper Limit
- 9.1
- value
- 7.16
- group Id
- OG013
- lower Limit
- 5.1
- upper Limit
- 15.7
- value
- 9.23
- 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
- 11
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 6
- 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. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- PK Population. Only those participants with data available at the specified data points were analyzed. 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: T1/2 of GSK3529246 (Active Metabolite) Following Single Dose Administration
- type
- SECONDARY
- unit Of Measure
- Hour
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Preserved source evidence · Not medical advice