TriangleNCT04537715 · OUTCOME
Part 1: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole
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
- Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 36
What was measured
Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
Analysis population: The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
Groups in this outcome
Part 1: Tazemetostat + Itraconazole
Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. A single oral dose of 200 mg itraconazole was administered daily from Day 18 to Day 20. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Itraconazole was also administered on Days 37 and 38 as a single oral 200 mg daily dose. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
| Group | Source count |
|---|---|
| Part 1: Tazemetostat + Itraconazole | 16 |
Reported measurements
Tazemetostat
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Tazemetostat + Itraconazole | 4530 | 64.5 | Not reported | Not reported | Not reported |
EPZ-6930
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Tazemetostat + Itraconazole | 5450 | 46.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 64.5
- value
- 4530
- title
- Tazemetostat
- categories
- measurements
- group Id
- OG000
- spread
- 46.6
- value
- 5450
- title
- EPZ-6930
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. A single oral dose of 200 mg itraconazole was administered daily from Day 18 to Day 20. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Itraconazole was also administered on Days 37 and 38 as a single oral 200 mg daily dose. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- id
- OG000
- title
- Part 1: Tazemetostat + Itraconazole
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 36
- title
- Part 1: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole
- type
- SECONDARY
- unit Of Measure
- h*ng/mL
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Preserved source evidence · Not medical advice