NCT06024174 · OUTCOME
Part 1: Time to Maximum Concentration (Tmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 1 (Each cycle consist of 28 days)
What was measured
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
Analysis population: Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only
Groups in this outcome
Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID
Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
| Group | Source count |
|---|---|
| Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID | NA | NA | Not reported | Not reported | No participants had adequate PK profiles (below lower limit of quantification). |
Complete source fields
- classes
- categories
- measurements
- comment
- No participants had adequate PK profiles (below lower limit of quantification).
- group Id
- OG000
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
- id
- OG000
- title
- Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (Each cycle consist of 28 days)
- title
- Part 1: Time to Maximum Concentration (Tmax)
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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