CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 146 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.

Search/NCT05327491
NCT05327491Phase 1Completed
CompareCT.gov

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

Amgen·interventional·Posted Apr 14, 2022·Updated Dec 14, 2023

In Brief

A Phase 1 clinical trial evaluating Sotorasib for Healthy Participants. Completed, enrolled 146 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedApr 14, 2022
Enrollment StartMar 21, 2022
Primary CompletionJul 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.2 years ago

Interventions

Sotorasibdrug

Oral Tablet