TriangleNCT01072175 · OUTCOME
Part D (Analyte=GSK2118436): Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- Time frame
- Day 1 and Day 21
What was measured
tmax is defined as the time of occurenceof Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.
Analysis population: PK Population. Only participants available at the indicated timepoints were analyzed.
Groups in this outcome
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 15 |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 14 |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 15 |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 15 |
Reported measurements
Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 2.00 | Not reported | 1.00 | 3.00 | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 2.00 | Not reported | 1.00 | 6.00 | Not reported |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 2.00 | Not reported | 1.00 | 3.00 | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 1.50 | Not reported | 1.00 | 10.00 | Not reported |
Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1.50 | Not reported | 1.00 | 2.00 | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 1.55 | Not reported | 0.98 | 3.00 | Not reported |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1.75 | Not reported | 1.00 | 3.00 | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 1.50 | Not reported | 1.00 | 3.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 2.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 6.00
- value
- 2.00
- group Id
- OG002
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 2.00
- group Id
- OG003
- lower Limit
- 1.00
- upper Limit
- 10.00
- value
- 1.50
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.50
- group Id
- OG001
- lower Limit
- 0.98
- upper Limit
- 3.00
- value
- 1.55
- group Id
- OG002
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.75
- group Id
- OG003
- lower Limit
- 1.00
- upper Limit
- 3.00
- value
- 1.50
- title
- Day 21
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 15
- units
- Participants
- description
- tmax is defined as the time of occurenceof Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.
- dispersion Type
- Full Range
- groups
- description
- Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG000
- title
- Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG001
- title
- Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part D: Dabrafenib 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG003
- title
- Part D: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- MEDIAN
- population Description
- PK Population. Only participants available at the indicated timepoints were analyzed.
- reporting Status
- POSTED
- time Frame
- Day 1 and Day 21
- title
- Part D (Analyte=GSK2118436): Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib
- type
- PRIMARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice