TriangleNCT01943851 · OUTCOME
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single 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 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
What was measured
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Analysis population: PK Population consisted of all participants in the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
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 | 5 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 8 |
| Part 1: GSK525762 60 mg QD NHL | 18 |
| Part 1: GSK525762 60 mg QD MM | 3 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 6 |
| Part 1: GSK525762 80 mg QD NHL | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 6 |
Reported measurements
AUC(0-24), n=1,1,1,5,1,4,8,18,3,8,1,6,7,16, 6
| 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 | 5 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 8 |
| Part 1: GSK525762 60 mg QD NHL | 18 |
| Part 1: GSK525762 60 mg QD MM | 3 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 6 |
| Part 1: GSK525762 80 mg QD NHL | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 460.48 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK525762 10 mg QD | 1024.49 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 2881.41 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 2146.54 | 31.68 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 3317.10 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 2510.55 | 71.29 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 6424.74 | 22.42 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 5918.90 | 52.85 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 3695.32 | 62.01 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 7980.72 | 45.28 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5944.52 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 8394.69 | 34.31 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 5017.96 | 44.17 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 13520.57 | 46.29 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 13688.54 | 43.80 | Not reported | Not reported | Not reported |
AUC(0-inf), n=1,1,1,5,1,4,7,17,3,8,1,5,7,16,5
| 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 | 5 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 7 |
| Part 1: GSK525762 60 mg QD NHL | 17 |
| Part 1: GSK525762 60 mg QD MM | 3 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 5 |
| Part 1: GSK525762 80 mg QD NHL | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 466.81 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 1092.28 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 3054.11 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 2217.32 | 32.55 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 3465.49 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 2546.49 | 72.05 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 6951.06 | 25.12 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 6214.97 | 60.67 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 3874.05 | 63.27 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 8248.45 | 47.87 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 6032.36 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 9734.83 | 29.60 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 5114.61 | 44.76 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 14635.17 | 52.35 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 17021.44 | 35.37 | 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
- 460.48
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 1024.49
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 2881.41
- group Id
- OG003
- spread
- 31.68
- value
- 2146.54
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 3317.10
- group Id
- OG005
- spread
- 71.29
- value
- 2510.55
- group Id
- OG006
- spread
- 22.42
- value
- 6424.74
- group Id
- OG007
- spread
- 52.85
- value
- 5918.90
- group Id
- OG008
- spread
- 62.01
- value
- 3695.32
- group Id
- OG009
- spread
- 45.28
- value
- 7980.72
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 5944.52
- group Id
- OG011
- spread
- 34.31
- value
- 8394.69
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- AUC(0-24), n=1,1,1,5,1,4,8,18,3,8,1,6,7,16, 6
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 466.81
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 1092.28
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 3054.11
- group Id
- OG003
- spread
- 32.55
- value
- 2217.32
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 3465.49
- group Id
- OG005
- spread
- 72.05
- value
- 2546.49
- group Id
- OG006
- spread
- 25.12
- value
- 6951.06
- group Id
- OG007
- spread
- 60.67
- value
- 6214.97
- group Id
- OG008
- spread
- 63.27
- value
- 3874.05
- group Id
- OG009
- spread
- 47.87
- value
- 8248.45
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 6032.36
- group Id
- OG011
- spread
- 29.60
- value
- 9734.83
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- AUC(0-inf), n=1,1,1,5,1,4,7,17,3,8,1,5,7,16,5
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
- 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 consisted of all participants in the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
- reporting Status
- POSTED
- time Frame
- Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
- title
- Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single 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