TriangleNCT01943851 · OUTCOME
Part 2: Apparent Central Volume of Distribution (V1/F) 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
- MEAN
- Unit
- Liters
- Interval / dispersion
- Standard Deviation
- Time frame
- Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 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 empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Analysis population: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS \& N=0 for 80 mg QC CTCL arm for this outcome measure.
Groups in this outcome
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
| Group | Source count |
|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 7 |
| Part 2: GSK525762 75 mg QD MDS | 17 |
| Part 2: GSK525762 80 mg QD CTCL | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 51.5 | 19.50 | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 47.9 | 8.01 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.50
- value
- 51.5
- group Id
- OG001
- spread
- 8.01
- value
- 47.9
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG000
- title
- Part 2: GSK525762 60 mg QD CTCL
- description
- Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
- id
- OG001
- title
- Part 2: GSK525762 75 mg QD MDS
- description
- Participants CTCL were administered once daily oral dose of 80 mg GSK525762
- id
- OG002
- title
- Part 2: GSK525762 80 mg QD CTCL
- param Type
- MEAN
- population Description
- PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS \& N=0 for 80 mg QC CTCL arm for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
- title
- Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Single Dose Administration
- type
- SECONDARY
- unit Of Measure
- Liters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice