At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Sotorasibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Single-dose Study to Evaluate the Pharmacokinetics of Sotorasib in Healthy Subjects and Subjects With Moderate or Severe Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Sotorasib for Hepatic Impairment. Completed, enrolled 20 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedMay 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedMay 14, 2021
Enrollment StartApr 22, 2021
Primary CompletionMar 9, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.1 years ago
Interventions
Sotorasibdrug
Sotorasib will be administered as an oral tablet.