drugset / Trial / NCT05327491
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.
Timeline
- Start
- 2022-03-21
- Primary completion
- 2022-07-17
- Completion
- 2022-07-17
Outcome
Met primary endpoint
registry analysis (equivalence test); Treatment A vs Treatment B; Ratio of GLSM 0.962 (90% CI 0.880 to 1.053) NCT05327491 ↗
registry analysis (equivalence test); Treatment A vs Treatment B; Ratio of GLSM 0.968 (90% CI 0.907 to 1.033) NCT05327491 ↗
registry analysis (equivalence test); Treatment A vs Treatment B; Ratio of GLSM 0.967 (90% CI 0.908 to 1.029) NCT05327491 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotorasib | Small molecule | — | Oral |
Indications
No indication recorded.