drugset / Trial / NCT06061523
A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants
RandomizedCrossoverOpen-labelBasic science
Summary
The primary objectives of the study are to compare the pharmacokinetics (PK) and demonstrate relative bioavailability of sotorasib administered as 4 oral tablets (test) to sotorasib administered as 8 oral tablets (reference) and to assess the effect of food on the PK of sotorasib administered as 4 oral tablets.
Timeline
- Start
- 2024-07-15
- Primary completion
- 2024-09-09
- Completion
- 2024-09-09
Outcome
Outcome not reported
Stopped: “FDA and EMA agreed existing data are appropriate for approval and no further BE studies are required.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotorasib | Small molecule | — | Oral |
Indications
No indication recorded.