TriangleNCT01943851 · OUTCOME
Part 1: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 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
- Hours*nanograms per milliliter
- 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 PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. AUC(0-24) represents AUC(0-tau) for repeat dose.
Analysis population: PK Population. Only those participants with data available at the specified data points were analyzed.
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 | 1 |
| Part 1: GSK525762 10 mg QD | 1 |
| Part 1: GSK525762 20 mg QD | 1 |
| Part 1: GSK525762 30 mg QD MM | 4 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 3 |
| Part 1: GSK525762 60 mg QD NHL | 11 |
| Part 1: GSK525762 60 mg QD MM | 2 |
| Part 1: GSK525762 75 mg QD AML | 7 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 6 |
| Part 1: GSK525762 80 mg QD NHL | 4 |
| Part 1: GSK525762 100 mg QD AML | 11 |
| Part 1: GSK525762 120 mg QD AML | 2 |
Reported measurements
AUC(0-24)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 476.71 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 656.93 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 1855.07 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 1908.18 | 27.53 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 2490.25 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 1702.37 | 58.17 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 6271.43 | 38.76 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 3576.49 | 30.59 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 931.02 | 53.64 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 5883.76 | 48.48 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5188.25 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 6892.57 | 71.96 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 2994.24 | 37.27 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 9440.98 | 84.11 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 5296.46 | 8.89 | Not reported | Not reported | Not reported |
AUC(0-tau)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 476.71 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 656.93 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 1855.07 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 1908.18 | 27.53 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 2490.25 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 1702.37 | 58.17 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 6271.43 | 38.76 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 3576.49 | 30.59 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 931.02 | 53.64 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 5883.76 | 48.48 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5188.25 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 6892.57 | 71.96 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 2994.24 | 37.27 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 9440.98 | 84.11 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 5296.46 | 8.89 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 476.71
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 656.93
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 1855.07
- group Id
- OG003
- spread
- 27.53
- value
- 1908.18
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 2490.25
- group Id
- OG005
- spread
- 58.17
- value
- 1702.37
- group Id
- OG006
- spread
- 38.76
- value
- 6271.43
- group Id
- OG007
- spread
- 30.59
- value
- 3576.49
- group Id
- OG008
- spread
- 53.64
- value
- 931.02
- group Id
- OG009
- spread
- 48.48
- value
- 5883.76
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 5188.25
- group Id
- OG011
- spread
- 71.96
- value
- 6892.57
- title
- AUC(0-24)
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 476.71
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 656.93
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 1855.07
- group Id
- OG003
- spread
- 27.53
- value
- 1908.18
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 2490.25
- group Id
- OG005
- spread
- 58.17
- value
- 1702.37
- group Id
- OG006
- spread
- 38.76
- value
- 6271.43
- group Id
- OG007
- spread
- 30.59
- value
- 3576.49
- group Id
- OG008
- spread
- 53.64
- value
- 931.02
- group Id
- OG009
- spread
- 48.48
- value
- 5883.76
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 5188.25
- group Id
- OG011
- spread
- 71.96
- value
- 6892.57
- title
- AUC(0-tau)
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 7
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. AUC(0-24) represents AUC(0-tau) for repeat dose.
- 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.
- 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: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 Following Repeat 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