NCT05436912

A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants

Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-292 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy participants. Information about safety and tolerability will be collected. The study will last up to about 7 weeks, inclusive of screening period.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Selpercatinib	Administered orally.

Timeline

• Start date: 2018-12-10
• Primary completion: 2019-10-04
• Completion: 2019-10-30
• First posted: 2022-06-29
• Last updated: 2025-04-13
• Results posted: 2025-04-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study