TriangleNCT01943851 · OUTCOME
Part 1: Trough Concentration (Ctau) 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 on Days 4, 6 and 7
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 0.91 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 10 mg QD | 3.90 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 20 mg QD | 3.76 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 30 mg QD MM | 4.88 | 78.94 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 8.12 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 40 mg QD MM | 2.26 | 114.63 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 32.85 | 88.47 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 5.99 | 41.92 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 0.03 | 128.56 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 13.21 | 102.35 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 2.08 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated for a single participant |
| Part 1: GSK525762 80 mg QD AML | 15.77 | 123.78 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 2.25 | 92.05 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 42.18 | 139.74 | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 14.34 | 68.62 | 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
- 0.91
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG001
- spread
- NA
- value
- 3.90
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG002
- spread
- NA
- value
- 3.76
- group Id
- OG003
- spread
- 78.94
- value
- 4.88
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG004
- spread
- NA
- value
- 8.12
- group Id
- OG005
- spread
- 114.63
- value
- 2.26
- group Id
- OG006
- spread
- 88.47
- value
- 32.85
- group Id
- OG007
- spread
- 41.92
- value
- 5.99
- group Id
- OG008
- spread
- 128.56
- value
- 0.03
- group Id
- OG009
- spread
- 102.35
- value
- 13.21
- comment
- Geometric coefficient of variation could not be calculated for a single participant
- group Id
- OG010
- spread
- NA
- value
- 2.08
- group Id
- OG011
- spread
- 123.78
- value
- 15.77
- 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 on Days 4, 6 and 7
- title
- Part 1: Trough Concentration (Ctau) 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