NCT06215521

A Study to Evaluate the Effect of Pirtobrutinib (LOXO-305) on QTc Interval in Healthy Participants

A Phase I, Single-Dose, Randomized, Partially Double-Blind, Placebo- and Positive-Controlled, 3-Way Crossover Study to Evaluate the Effect of LOXO-305 on QTc Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (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 the heart rate-corrected QT (QTc) interval and to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib. The study will also evaluate the safety and tolerability of pirtobrutinib. The study will last up to 71 days, including screening.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Administered orally
DRUG	Placebo	Administered orally
DRUG	Moxifloxacin	Administered orally

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2024-01-22
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study