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CompletedNCT05089019

A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
224 (actual)
Sponsor
Loxo Oncology, Inc. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSelpercatinibAdministered orally

Timeline

Start date
2021-10-29
Primary completion
2022-07-19
Completion
2022-07-19
First posted
2021-10-22
Last updated
2025-03-17
Results posted
2025-03-17

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05089019. Inclusion in this directory is not an endorsement.

A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants (NCT05089019) · Clinical Trials Directory