NCT06190691

Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants

An Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-305 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 – 75 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last about 46 days.

Conditions

• Healthy
• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Administered orally

Timeline

• Start date: 2020-12-18
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2024-01-05
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study