TriangleNCT01072175 · OUTCOME
Part C: Oral Clearance (CL/F) of Dabrafenib and Trametinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Liters per hour (L/hr)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
What was measured
Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.
Analysis population: PK Population
Groups in this outcome
Part C: Dabrafenib 150 mg
Participants received dabrafenib 150 mg gelatin capsules BID.
Part C: Trametinib
Participants received Trametinib 1 mg or 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 53 |
| Part C: Trametinib | 109 |
Reported measurements
Non-inducible
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 53 |
| Part C: Trametinib | 109 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: Dabrafenib 150 mg | 19.4 | Not reported | 17.6 | 21.2 | Not reported |
| Part C: Trametinib | 5.07 | Not reported | 4.83 | 5.31 | Not reported |
Inducible
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 53 |
| Part C: Trametinib | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: Dabrafenib 150 mg | 20.0 | Not reported | 19.2 | 20.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.6
- upper Limit
- 21.2
- value
- 19.4
- group Id
- OG001
- lower Limit
- 4.83
- upper Limit
- 5.31
- value
- 5.07
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 109
- units
- Participants
- title
- Non-inducible
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.2
- upper Limit
- 20.8
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Inducible
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received dabrafenib 150 mg gelatin capsules BID.
- id
- OG000
- title
- Part C: Dabrafenib 150 mg
- description
- Participants received Trametinib 1 mg or 2 mg tablets QD.
- id
- OG001
- title
- Part C: Trametinib
- param Type
- MEAN
- population Description
- PK Population
- reporting Status
- POSTED
- time Frame
- Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
- title
- Part C: Oral Clearance (CL/F) of Dabrafenib and Trametinib
- type
- SECONDARY
- unit Of Measure
- Liters per hour (L/hr)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice