NCT06180967

A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Different Formulations of Midazolam 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 the Pharmacokinetics of a Single Dose of Intravenous and Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (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 assess the effect of Pirtobrutinib (LOXO-305) on how fast different formulations of midazolam gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. The study will also access how much endogenous coproporphyrins I and III as biomarkers of OATP1B1 and OATP1B3 is in the bloodstream and how the body handles and eliminates them following single and multiple oral doses of Pirtobrutinib. Safety and tolerability of Pirtobrutinib will also be evaluated. For each participant, the total duration of the study will be 59 days, including screening.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Midazolam Syrup	Administered Orally.
DRUG	Midazolam Solution	Administered IV bolus.
DRUG	Pirtobrutinib	Administered Orally.

Timeline

• Start date: 2020-09-03
• Primary completion: 2020-10-20
• Completion: 2020-10-20
• First posted: 2023-12-26
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study