CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 145 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/NCT05048784
NCT05048784Phase 1Completed
CompareCT.gov

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

Amgen·interventional·Posted Sep 17, 2021·Updated Sep 18, 2023

In Brief

A Phase 1 clinical trial evaluating Sotorasib for Healthy Participants. Completed, enrolled 145 participants across 2 sites.

Detailed 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).

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartAug 16, 2021
Primary CompletionFeb 18, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.8 years ago

Interventions

Sotorasibdrug

Oral tablet