NCT01587703 · OUTCOME
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16
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 milliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
What was measured
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose 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 20 mg BID
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Reported measurements
AUC (0 to 24); Week1 AM dose;n=3,10,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 3 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 856.1 | 123.7 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 3067.0 | 43.9 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 2794.4 | 31.8 | Not reported | Not reported | Not reported |
|---|
AUC (0 to 24); Week1 PM dose;n=4,7,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 7 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 981.4 | 84.8 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 3261.1 | 59.9 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 2607.6 | 36.2 | Not reported | Not reported | Not reported |
|---|
AUC (0 to 24); Week3 AM dose;n=3,7,3
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 3 |
|---|
| Part 1: GSK525762 30 mg BID | 7 |
|---|
| Part 1: GSK525762 40 mg BID | 3 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 1279.0 | 116.2 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 2725.3 | 92.4 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1184.6 | 17.8 | Not reported | Not reported | Not reported |
|---|
AUC (0 to 24); Week3 PM dose;n=3,5,3
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 3 |
|---|
| Part 1: GSK525762 30 mg BID | 5 |
|---|
| Part 1: GSK525762 40 mg BID | 3 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 1155.8 | 102.4 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 1662.1 | 29.2 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1131.6 | 28.5 | Not reported | Not reported | Not reported |
|---|
AUC (0 to inf); Week1 AM dose;n=3,10,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 3 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 860.4 | 124.4 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 3118.3 | 45.3 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 2825.8 | 32.8 | Not reported | Not reported | Not reported |
|---|
AUC (0 to t); Week1 AM dose;n=4,10,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 932.2 | 97.6 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 2727.2 | 40.8 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 2579.0 | 28.0 | Not reported | Not reported | Not reported |
|---|
AUC (0 to t); Week1 PM dose;n=4,9,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 9 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 927.5 | 82.5 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 2840.4 | 43.4 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 2446.7 | 34.2 | Not reported | Not reported | Not reported |
|---|
AUC (0 to t); Week3 AM dose;n=3,7,3
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 3 |
|---|
| Part 1: GSK525762 30 mg BID | 7 |
|---|
| Part 1: GSK525762 40 mg BID | 3 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 1194.6 | 110.1 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 2472.4 | 89.8 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1140.9 | 16.9 | Not reported | Not reported | Not reported |
|---|
AUC (0 to t); Week3 PM dose;n=3,6,3
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 3 |
|---|
| Part 1: GSK525762 30 mg BID | 6 |
|---|
| Part 1: GSK525762 40 mg BID | 3 |
|---|
Values in Hours*nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 1053.6 | 96.6 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 1490.8 | 23.3 | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1073.6 | 29.2 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 123.7
- value
- 856.1
- group Id
- OG001
- spread
- 43.9
- value
- 3067.0
- group Id
- OG002
- spread
- 31.8
- value
- 2794.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- AUC (0 to 24); Week1 AM dose;n=3,10,5
- categories
- measurements
- group Id
- OG000
- spread
- 84.8
- value
- 981.4
- group Id
- OG001
- spread
- 59.9
- value
- 3261.1
- group Id
- OG002
- spread
- 36.2
- value
- 2607.6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- AUC (0 to 24); Week1 PM dose;n=4,7,5
- categories
- measurements
- group Id
- OG000
- spread
- 116.2
- value
- 1279.0
- group Id
- OG001
- spread
- 92.4
- value
- 2725.3
- group Id
- OG002
- spread
- 17.8
- value
- 1184.6
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- AUC (0 to 24); Week3 AM dose;n=3,7,3
- categories
- measurements
- group Id
- OG000
- spread
- 102.4
- value
- 1155.8
- group Id
- OG001
- spread
- 29.2
- value
- 1662.1
- group Id
- OG002
- spread
- 28.5
- value
- 1131.6
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- AUC (0 to 24); Week3 PM dose;n=3,5,3
- categories
- measurements
- group Id
- OG000
- spread
- 124.4
- value
- 860.4
- group Id
- OG001
- spread
- 45.3
- value
- 3118.3
- group Id
- OG002
- spread
- 32.8
- value
- 2825.8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- AUC (0 to inf); Week1 AM dose;n=3,10,5
- categories
- measurements
- group Id
- OG000
- spread
- 97.6
- value
- 932.2
- group Id
- OG001
- spread
- 40.8
- value
- 2727.2
- group Id
- OG002
- spread
- 28.0
- value
- 2579.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- AUC (0 to t); Week1 AM dose;n=4,10,5
- categories
- measurements
- group Id
- OG000
- spread
- 82.5
- value
- 927.5
- group Id
- OG001
- spread
- 43.4
- value
- 2840.4
- group Id
- OG002
- spread
- 34.2
- value
- 2446.7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- AUC (0 to t); Week1 PM dose;n=4,9,5
- categories
- measurements
- group Id
- OG000
- spread
- 110.1
- value
- 1194.6
- group Id
- OG001
- spread
- 89.8
- value
- 2472.4
- group Id
- OG002
- spread
- 16.9
- value
- 1140.9
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- AUC (0 to t); Week3 AM dose;n=3,7,3
- categories
- measurements
- group Id
- OG000
- spread
- 96.6
- value
- 1053.6
- group Id
- OG001
- spread
- 23.3
- value
- 1490.8
- group Id
- OG002
- spread
- 29.2
- value
- 1073.6
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- AUC (0 to t); Week3 PM dose;n=3,6,3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 20 mg BID
- description
- Participants were administered twice daily oral dose of 30 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 30 mg BID
- description
- Participants were administered twice daily oral dose of 40 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 40 mg BID
- 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 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
- title
- AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
- type
- SECONDARY
- unit Of Measure
- Hours*nanogram per milliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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