NCT04887064

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

An Open-label Single-dose Study to Evaluate the Pharmacokinetics of Sotorasib in Healthy Subjects and Subjects With Moderate or Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Sotorasib	Sotorasib will be administered as an oral tablet.

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-03-09
• Completion: 2022-03-09
• First posted: 2021-05-14
• Last updated: 2024-04-19
• Results posted: 2024-04-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study