NCT05048784

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

An Open-label, Randomized, Two-way Crossover, Bioequivalence Study in Healthy Volunteers to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Sotorasib	Oral tablet

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2021-09-17
• Last updated: 2023-09-18
• Results posted: 2023-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study