CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 224 enrolled
Drug / intervention
Selpercatinibdrug
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/NCT05089019
NCT05089019Phase 1Completed

An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations

Loxo Oncology, Inc.·interventional·Posted Oct 22, 2021·Updated Mar 17, 2025

In Brief

A Phase 1 clinical trial evaluating Selpercatinib for Healthy. Completed, enrolled 224 participants across 4 sites.

Detailed Summary

The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as different formulations. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 56 days including the 28 days of screening period.

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedOct 22, 2021
Enrollment StartOct 29, 2021
Primary CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.7 years ago

Interventions

Selpercatinibdrug

Administered orally