TriangleNCT01587703 · OUTCOME
AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Hours*nanogram per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
What was measured
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained.
Analysis population: PK Parameter Population. Only those participants with data available at the specified time points were available (indicated by n=X in category titles)
Groups in this outcome
Part 1: GSK525762 2 mg QD
Participants were administered once daily oral dose of 2 mg GSK525762.
Part 1: GSK525762 4 mg QD
Participants were administered once daily oral dose of 4 mg GSK525762.
Part 1: GSK525762 8 mg QD
Participants were administered once daily oral dose of 8 mg GSK525762.
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 3 |
| Part 1: GSK525762 4 mg QD | 4 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 9 |
| Part 1: GSK525762 80 mg QD | 32 |
| Part 1: GSK525762 100 mg QD | 9 |
Reported measurements
AUC (0 to 24); Week1;n=3,4,1,3,4,9,32,9
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 3 |
| Part 1: GSK525762 4 mg QD | 4 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 9 |
| Part 1: GSK525762 80 mg QD | 32 |
| Part 1: GSK525762 100 mg QD | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 169.2 | 39.4 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 354.3 | 33.8 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 431.5 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 16 mg QD | 867.9 | 39.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 3943.2 | 49.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 4225.0 | 39.2 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5692.4 | 61.4 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 6958.3 | 43.5 | Not reported | Not reported | Not reported |
AUC (0 to 24); Week3;n=1,2,1,3,4,6,16,6
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 1 |
| Part 1: GSK525762 4 mg QD | 2 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 6 |
| Part 1: GSK525762 80 mg QD | 16 |
| Part 1: GSK525762 100 mg QD | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 152.9 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 4 mg QD | 334.6 | 60.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 329.5 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 16 mg QD | 671.6 | 21.4 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 3146.2 | 54.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 2575.6 | 47.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 2959.8 | 48.4 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 3818.5 | 35.8 | Not reported | Not reported | Not reported |
AUC (0 to inf); Week1;n=3,4,1,3,4,9,32,9
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 3 |
| Part 1: GSK525762 4 mg QD | 4 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 9 |
| Part 1: GSK525762 80 mg QD | 32 |
| Part 1: GSK525762 100 mg QD | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 174.4 | 44.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 360.8 | 35.1 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 433.1 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 16 mg QD | 887.1 | 39.1 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 4464.5 | 62.9 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 4357.5 | 42.1 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5887.2 | 62.8 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 7295.6 | 45.2 | Not reported | Not reported | Not reported |
AUC (0 to t); Week1;n=3,4,1,3,4,9,32,9
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 3 |
| Part 1: GSK525762 4 mg QD | 4 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 9 |
| Part 1: GSK525762 80 mg QD | 32 |
| Part 1: GSK525762 100 mg QD | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 168.6 | 44.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 357.5 | 34.8 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 431.1 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 16 mg QD | 877.7 | 39.4 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 4147.8 | 54.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 4304.1 | 40.7 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5667.3 | 61.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 7218.4 | 45.1 | Not reported | Not reported | Not reported |
AUC (0 to t); Week3;n=1,2,1,3,4,6,16,6
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 1 |
| Part 1: GSK525762 4 mg QD | 2 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 6 |
| Part 1: GSK525762 80 mg QD | 16 |
| Part 1: GSK525762 100 mg QD | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 152.8 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 4 mg QD | 334.3 | 60.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 330.6 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point. |
| Part 1: GSK525762 16 mg QD | 672.3 | 21.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 3164.3 | 54.7 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 2576.9 | 47.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 2953.8 | 49.0 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 3819.9 | 35.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39.4
- value
- 169.2
- group Id
- OG001
- spread
- 33.8
- value
- 354.3
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG002
- spread
- NA
- value
- 431.5
- group Id
- OG003
- spread
- 39.5
- value
- 867.9
- group Id
- OG004
- spread
- 49.5
- value
- 3943.2
- group Id
- OG005
- spread
- 39.2
- value
- 4225.0
- group Id
- OG006
- spread
- 61.4
- value
- 5692.4
- group Id
- OG007
- spread
- 43.5
- value
- 6958.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- AUC (0 to 24); Week1;n=3,4,1,3,4,9,32,9
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG000
- spread
- NA
- value
- 152.9
- group Id
- OG001
- spread
- 60.5
- value
- 334.6
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG002
- spread
- NA
- value
- 329.5
- group Id
- OG003
- spread
- 21.4
- value
- 671.6
- group Id
- OG004
- spread
- 54.5
- value
- 3146.2
- group Id
- OG005
- spread
- 47.3
- value
- 2575.6
- group Id
- OG006
- spread
- 48.4
- value
- 2959.8
- group Id
- OG007
- spread
- 35.8
- value
- 3818.5
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 16
- group Id
- OG007
- value
- 6
- units
- Participants
- title
- AUC (0 to 24); Week3;n=1,2,1,3,4,6,16,6
- categories
- measurements
- group Id
- OG000
- spread
- 44.3
- value
- 174.4
- group Id
- OG001
- spread
- 35.1
- value
- 360.8
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG002
- spread
- NA
- value
- 433.1
- group Id
- OG003
- spread
- 39.1
- value
- 887.1
- group Id
- OG004
- spread
- 62.9
- value
- 4464.5
- group Id
- OG005
- spread
- 42.1
- value
- 4357.5
- group Id
- OG006
- spread
- 62.8
- value
- 5887.2
- group Id
- OG007
- spread
- 45.2
- value
- 7295.6
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- AUC (0 to inf); Week1;n=3,4,1,3,4,9,32,9
- categories
- measurements
- group Id
- OG000
- spread
- 44.5
- value
- 168.6
- group Id
- OG001
- spread
- 34.8
- value
- 357.5
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG002
- spread
- NA
- value
- 431.1
- group Id
- OG003
- spread
- 39.4
- value
- 877.7
- group Id
- OG004
- spread
- 54.3
- value
- 4147.8
- group Id
- OG005
- spread
- 40.7
- value
- 4304.1
- group Id
- OG006
- spread
- 61.5
- value
- 5667.3
- group Id
- OG007
- spread
- 45.1
- value
- 7218.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- AUC (0 to t); Week1;n=3,4,1,3,4,9,32,9
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG000
- spread
- NA
- value
- 152.8
- group Id
- OG001
- spread
- 60.3
- value
- 334.3
- comment
- Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
- group Id
- OG002
- spread
- NA
- value
- 330.6
- group Id
- OG003
- spread
- 21.5
- value
- 672.3
- group Id
- OG004
- spread
- 54.7
- value
- 3164.3
- group Id
- OG005
- spread
- 47.3
- value
- 2576.9
- group Id
- OG006
- spread
- 49.0
- value
- 2953.8
- group Id
- OG007
- spread
- 35.9
- value
- 3819.9
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 16
- group Id
- OG007
- value
- 6
- units
- Participants
- title
- AUC (0 to t); Week3;n=1,2,1,3,4,6,16,6
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 9
- units
- Participants
- description
- Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants were administered once daily oral dose of 2 mg GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 2 mg QD
- description
- Participants were administered once daily oral dose of 4 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 4 mg QD
- description
- Participants were administered once daily oral dose of 8 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 8 mg QD
- description
- Participants were administered once daily oral dose of 16 mg GSK525762.
- id
- OG003
- title
- Part 1: GSK525762 16 mg QD
- description
- Participants were administered once daily oral dose of 30 mg GSK525762.
- id
- OG004
- title
- Part 1: GSK525762 30 mg QD
- description
- Participants were administered once daily oral dose of 60 mg GSK525762.
- id
- OG005
- title
- Part 1: GSK525762 60 mg QD
- description
- Participants were administered once daily oral dose of 80 mg GSK525762.
- id
- OG006
- title
- Part 1: GSK525762 80 mg QD
- description
- Participants were administered once daily oral dose of 100 mg GSK525762.
- id
- OG007
- title
- Part 1: GSK525762 100 mg QD
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Parameter Population. Only those participants with data available at the specified time points were available (indicated by n=X in category titles)
- reporting Status
- POSTED
- time Frame
- pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
- title
- AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
- type
- SECONDARY
- unit Of Measure
- Hours*nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice