TriangleNCT01587703 · OUTCOME
Volume of Distribution 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
- Liters
- 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.
Analysis population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (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
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 | 53.56 | 65.9 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 81.79 | 34.7 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 79.87 | 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 | 182.13 | 92.7 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 85.46 | 30.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 110.44 | 23.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 87.03 | 56.4 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 124.70 | 42.6 | Not reported | Not reported | Not reported |
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 | 83.97 | 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 | 77.27 | 47.0 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 172.33 | 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 | 152.72 | 44.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 76.20 | 44.0 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 132.14 | 34.7 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 162.17 | 40.6 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 149.14 | 26.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 65.9
- value
- 53.56
- group Id
- OG001
- spread
- 34.7
- value
- 81.79
- 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
- 79.87
- group Id
- OG003
- spread
- 92.7
- value
- 182.13
- group Id
- OG004
- spread
- 30.3
- value
- 85.46
- group Id
- OG005
- spread
- 23.5
- value
- 110.44
- group Id
- OG006
- spread
- 56.4
- value
- 87.03
- group Id
- OG007
- spread
- 42.6
- value
- 124.70
- 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
- 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
- 83.97
- group Id
- OG001
- spread
- 47.0
- value
- 77.27
- 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
- 172.33
- group Id
- OG003
- spread
- 44.5
- value
- 152.72
- group Id
- OG004
- spread
- 44.0
- value
- 76.20
- group Id
- OG005
- spread
- 34.7
- value
- 132.14
- group Id
- OG006
- spread
- 40.6
- value
- 162.17
- group Id
- OG007
- spread
- 26.9
- value
- 149.14
- 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
- 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.
- 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 analyzed (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
- Volume of Distribution of GSK525762-Part 1 QD
- type
- SECONDARY
- unit Of Measure
- Liters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice