TriangleNCT04537715 · OUTCOME
Part 2: Least Squares Geometric Mean Ratio of Cmax After Tazemetostat at Steady State With Rifampin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_LEAST_SQUARES_MEAN
- Unit
- ratio
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose on Cycle 1 Day 15 (without rifampin) and Cycle 1 Day 24 (with rifampin)
What was measured
Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
Analysis population: The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 2 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or rifampin.
Groups in this outcome
Part 2: Tazemetostat + Rifampin
Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat co-administered with a single dose of oral 600 mg rifampin. On Day 24, subjects received a single dose of 800 mg tazemetostat co-administered with a single dose of oral 600 mg rifampin. Rifampin was also administered on Cycle 1 Day 25 as a single oral 600 mg dose. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (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 2: Tazemetostat + Rifampin | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Tazemetostat + Rifampin | 0.164 | Not reported | 0.122 | 0.219 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.122
- upper Limit
- 0.219
- value
- 0.164
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat co-administered with a single dose of oral 600 mg rifampin. On Day 24, subjects received a single dose of 800 mg tazemetostat co-administered with a single dose of oral 600 mg rifampin. Rifampin was also administered on Cycle 1 Day 25 as a single oral 600 mg dose. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (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 2: Tazemetostat + Rifampin
- param Type
- GEOMETRIC_LEAST_SQUARES_MEAN
- population Description
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 2 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or rifampin.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose on Cycle 1 Day 15 (without rifampin) and Cycle 1 Day 24 (with rifampin)
- title
- Part 2: Least Squares Geometric Mean Ratio of Cmax After Tazemetostat at Steady State With Rifampin
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice