TriangleNCT02603172 · OUTCOME
Part B: AUC(0-t) of GSK3039294 and GSK2315698
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- h*ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)
What was measured
Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t) was determined using standard non-compartmental methods.
Analysis population: PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Groups in this outcome
Part B: Cohort 3- GSK3039294 600 mg QD
Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
Part B: Cohort 4a- GSK3039294
Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
Part B: Cohort 4b- GSK3039294
Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
| Group | Source count |
|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 8 |
| Part B: Cohort 4a- GSK3039294 | 0 |
| Part B: Cohort 4b- GSK3039294 | 0 |
Reported measurements
GSK3039294: Day 4 (n= 0, 0, 0)
| Group | Source count |
|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 0 |
| Part B: Cohort 4a- GSK3039294 | 0 |
| Part B: Cohort 4b- GSK3039294 | 0 |
GSK2315698: Day 4 (n= 7, 0, 0)
| Group | Source count |
|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 7 |
| Part B: Cohort 4a- GSK3039294 | 0 |
| Part B: Cohort 4b- GSK3039294 | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 7571.9 | 30.12 | Not reported | Not reported | Not reported |
GSK3039294: Day 5 (n= 0, 0, 0)
| Group | Source count |
|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 0 |
| Part B: Cohort 4a- GSK3039294 | 0 |
| Part B: Cohort 4b- GSK3039294 | 0 |
GSK2315698: Day 5 (n= 8, 0, 0)
| Group | Source count |
|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 8 |
| Part B: Cohort 4a- GSK3039294 | 0 |
| Part B: Cohort 4b- GSK3039294 | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 8900.1 | 35.27 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- GSK3039294: Day 4 (n= 0, 0, 0)
- categories
- measurements
- group Id
- OG000
- spread
- 30.12
- value
- 7571.9
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- GSK2315698: Day 4 (n= 7, 0, 0)
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- GSK3039294: Day 5 (n= 0, 0, 0)
- categories
- measurements
- group Id
- OG000
- spread
- 35.27
- value
- 8900.1
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- GSK2315698: Day 5 (n= 8, 0, 0)
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t) was determined using standard non-compartmental methods.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
- id
- OG000
- title
- Part B: Cohort 3- GSK3039294 600 mg QD
- description
- Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
- id
- OG001
- title
- Part B: Cohort 4a- GSK3039294
- description
- Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
- id
- OG002
- title
- Part B: Cohort 4b- GSK3039294
- param Type
- GEOMETRIC_MEAN
- population Description
- PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
- reporting Status
- POSTED
- time Frame
- Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)
- title
- Part B: AUC(0-t) of GSK3039294 and GSK2315698
- type
- SECONDARY
- unit Of Measure
- h*ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice