NCT06180980

A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants

A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Pirtobrutinib (LOXO-305) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) after meals and on an empty stomach. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). Participants will stay in this study for up to 53 days (screening through follow-up call).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Administered orally.

Timeline

• Start date: 2021-01-04
• Primary completion: 2021-03-08
• Completion: 2021-03-08
• First posted: 2023-12-26
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study