NCT06061523

A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants

A Phase I, Open-label, Randomized Crossover Study to Evaluate the Relative Bioavailability and the Effect of Food for Sotorasib Tablets in Healthy Participants

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Sotorasib	Oral Tablet

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2023-09-29
• Last updated: 2024-04-12

Regulatory

• FDA-regulated drug study