TriangleNCT01587703 · OUTCOME
Maximum Observed Concentration for 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
- 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.
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 | 50.95 | 41.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 70.46 | 29.2 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 120.35 | 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 | 179.45 | 39.9 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 603.92 | 30.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 889.52 | 24.5 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 1099.81 | 62.7 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 1080.49 | 38.8 | 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 | 52.04 | 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 | 53.37 | 16.3 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 103.18 | 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 | 137.57 | 25.1 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 602.70 | 17.2 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 633.71 | 52.6 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 815.40 | 41.1 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 918.56 | 41.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 41.5
- value
- 50.95
- group Id
- OG001
- spread
- 29.2
- value
- 70.46
- 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
- 120.35
- group Id
- OG003
- spread
- 39.9
- value
- 179.45
- group Id
- OG004
- spread
- 30.3
- value
- 603.92
- group Id
- OG005
- spread
- 24.5
- value
- 889.52
- group Id
- OG006
- spread
- 62.7
- value
- 1099.81
- group Id
- OG007
- spread
- 38.8
- value
- 1080.49
- 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
- 52.04
- group Id
- OG001
- spread
- 16.3
- value
- 53.37
- 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
- 103.18
- group Id
- OG003
- spread
- 25.1
- value
- 137.57
- group Id
- OG004
- spread
- 17.2
- value
- 602.70
- group Id
- OG005
- spread
- 52.6
- value
- 633.71
- group Id
- OG006
- spread
- 41.1
- value
- 815.40
- group Id
- OG007
- spread
- 41.4
- value
- 918.56
- 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
- Maximum Observed Concentration for GSK525762-Part 1 QD
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice