TriangleNCT01943851 · OUTCOME
Part 1: Cmax and Cmin of GSK525762 Following Repeat 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 2 Day 7: 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 | 4 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 3 |
| Part 1: GSK525762 60 mg QD NHL | 11 |
| Part 1: GSK525762 60 mg QD MM | 2 |
| Part 1: GSK525762 75 mg QD AML | 7 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 6 |
| Part 1: GSK525762 80 mg QD NHL | 4 |
| Part 1: GSK525762 100 mg QD AML | 11 |
| Part 1: GSK525762 120 mg QD AML | 2 |
Reported measurements
Cmax
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 102.86 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 118.59 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 550.01 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 387.66 | 52.41 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 557.60 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 566.59 | 57.75 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 1070.32 | 37.26 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 1179.42 | 28.10 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 512.78 | 48.37 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 1384.46 | 35.35 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 1752.86 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 1314.21 | 58.58 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 725.29 | 46.79 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 1587.25 | 50.83 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 921.35 | 52.16 | Not reported | Not reported | Not reported |
Cmin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 1.47 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 5.03 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 3.92 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 7.72 | 103.48 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 8.66 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 2.36 | 84.21 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 57.75 | 82.69 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 7.03 | 51.10 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 1.63 | 141.42 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 14.00 | 112.58 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 21.02 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 50.89 | 123.69 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 4.64 | 73.29 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 55.63 | 163.06 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 14.96 | 64.95 | 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
- 102.86
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 118.59
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 550.01
- group Id
- OG003
- spread
- 52.41
- value
- 387.66
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 557.60
- group Id
- OG005
- spread
- 57.75
- value
- 566.59
- group Id
- OG006
- spread
- 37.26
- value
- 1070.32
- group Id
- OG007
- spread
- 28.10
- value
- 1179.42
- group Id
- OG008
- spread
- 48.37
- value
- 512.78
- group Id
- OG009
- spread
- 35.35
- value
- 1384.46
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 1752.86
- group Id
- OG011
- spread
- 58.58
- value
- 1314.21
- title
- Cmax
- categories
- measurements
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 1.47
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 5.03
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 3.92
- group Id
- OG003
- spread
- 103.48
- value
- 7.72
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 8.66
- group Id
- OG005
- spread
- 84.21
- value
- 2.36
- group Id
- OG006
- spread
- 82.69
- value
- 57.75
- group Id
- OG007
- spread
- 51.10
- value
- 7.03
- group Id
- OG008
- spread
- 141.42
- value
- 1.63
- group Id
- OG009
- spread
- 112.58
- value
- 14.00
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 21.02
- group Id
- OG011
- spread
- 123.69
- value
- 50.89
- title
- Cmin
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 7
- 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 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
- title
- Part 1: Cmax and Cmin of GSK525762 Following Repeat 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