TriangleNCT01943851 · OUTCOME
Part 1: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) 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
- Nanograms per milliliter (ng/mL)
- 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 PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Analysis population: PK Population. Only those participants with data available at the specified data points were analyzed.
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
Cmax
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 90.56 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 116.69 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 559.14 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 442.77 | 31.83 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 513.03 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 660.79 | 71.94 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 853.03 | 31.1 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 1158.66 | 28.58 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 813.87 | 27.91 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 1728.80 | 35.37 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 1248.10 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 1444.42 | 29.92 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 1073.51 | 38.46 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 2335.99 | 23.05 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 1793.39 | 42.16 | Not reported | Not reported | Not reported |
Cmin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 1.11 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 27.86 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 20.62 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 7.55 | 73.07 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 21.20 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 13.25 | 71.79 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 107.30 | 68.40 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 50.49 | 139.83 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 29.39 | 47.67 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 37.92 | 80.33 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 129.76 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 71.43 | 112.42 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 27.89 | 115.67 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 89.96 | 112.80 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 138.75 | 111.14 | 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
- 90.56
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 116.69
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 559.14
- group Id
- OG003
- spread
- 31.83
- value
- 442.77
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 513.03
- group Id
- OG005
- spread
- 71.94
- value
- 660.79
- group Id
- OG006
- spread
- 31.1
- value
- 853.03
- group Id
- OG007
- spread
- 28.58
- value
- 1158.66
- group Id
- OG008
- spread
- 27.91
- value
- 813.87
- group Id
- OG009
- spread
- 35.37
- value
- 1728.80
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 1248.10
- group Id
- OG011
- spread
- 29.92
- value
- 1444.42
- title
- Cmax
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 1.11
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 27.86
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 20.62
- group Id
- OG003
- spread
- 73.07
- value
- 7.55
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 21.20
- group Id
- OG005
- spread
- 71.79
- value
- 13.25
- group Id
- OG006
- spread
- 68.40
- value
- 107.30
- group Id
- OG007
- spread
- 139.83
- value
- 50.49
- group Id
- OG008
- spread
- 47.67
- value
- 29.39
- group Id
- OG009
- spread
- 80.33
- value
- 37.92
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 129.76
- group Id
- OG011
- spread
- 112.42
- value
- 71.43
- title
- Cmin
- 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 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. Only those participants with data available at the specified data points were analyzed.
- 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: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) of GSK525762 Following Single Dose Administration
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice