NCT06215430

A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants

A Phase I, Open-label, Fixed-sequence, Drug Interaction Study to Investigate the Effect of Multiple Oral Doses of LOXO-305 on CYP1A2, CYP2C9, and CYP2C19 Substrates Using a Probe Drug Cocktail in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 evaluate the effect of LOXO-305 on single oral dose of caffeine cytochrome P450 1A2 (CYP1A2) substrate, S-warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate) when administered as multiple doses by collecting the blood samples and conducting the blood tests to measure how much LOXO-305 is in the bloodstream and how the body handles and eliminates LOXO-305 in adult healthy participants. The study will also evaluate the safety and tolerability of LOXO-305. The study will be conducted in two periods. Participants will stay in this study for up to 67 days, including screening.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Caffeine Tablet	Administered orally.
DRUG	Omeprazole capsule	Administered orally.
DRUG	Warfarin tablet	Administered orally.
DRUG	Pirtobrutinib	Administered orally.

Timeline

• Start date: 2021-01-11
• Primary completion: 2021-04-15
• Completion: 2021-04-15
• First posted: 2024-01-22
• Last updated: 2025-03-10
• Results posted: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study