TriangleNCT01943851 · OUTCOME
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Repeat 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 2 Day 7: 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. 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 | 4 |
| 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 | 9 |
| 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 | 4 |
| Part 1: GSK525762 100 mg QD AML | 11 |
| Part 1: GSK525762 120 mg QD AML | 0 |
Reported measurements
Cmax
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 121.83 | 26.75 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 282.72 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 60 mg QD NHL | 453.89 | 34.07 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 500.61 | 22.83 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 445.47 | 52.02 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 370.67 | 35.23 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 557.92 | 31.81 | Not reported | Not reported | Not reported |
Cmin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 30 mg QD MM | 27.14 | 28.38 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 15.18 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 60 mg QD NHL | 66.49 | 81.56 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 40.88 | 45.39 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 73.60 | 88.34 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 38.71 | 56.34 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 116.62 | 74.25 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- spread
- 26.75
- value
- 121.83
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG005
- spread
- NA
- value
- 282.72
- group Id
- OG007
- spread
- 34.07
- value
- 453.89
- group Id
- OG008
- spread
- 22.83
- value
- 500.61
- group Id
- OG009
- spread
- 52.02
- value
- 445.47
- group Id
- OG012
- spread
- 35.23
- value
- 370.67
- group Id
- OG013
- spread
- 31.81
- value
- 557.92
- title
- Cmax
- categories
- measurements
- group Id
- OG003
- spread
- 28.38
- value
- 27.14
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG005
- spread
- NA
- value
- 15.18
- group Id
- OG007
- spread
- 81.56
- value
- 66.49
- group Id
- OG008
- spread
- 45.39
- value
- 40.88
- group Id
- OG009
- spread
- 88.34
- value
- 73.60
- group Id
- OG012
- spread
- 56.34
- value
- 38.71
- group Id
- OG013
- spread
- 74.25
- value
- 116.62
- title
- Cmin
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 7
- 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. 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 2 Day 7: 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 Repeat Dose Administration
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter (ng/mL)
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Preserved source evidence · Not medical advice