NCT05327491

A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

An Open-label, Randomized, Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Sotorasib	Oral Tablet

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-07-17
• Completion: 2022-07-17
• First posted: 2022-04-14
• Last updated: 2023-12-14
• Results posted: 2023-12-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study