NCT06153355

A First-In-Human Study of LY3839840 in Healthy Participants

Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3839840 Following Oral Dosing in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this first-in-human study to investigate the safety of LY3839840 in single and multiple doses, and how it's processed in the body when given in different amounts.

Detailed description

The study will be conducted in five parts (A, B, C, D, and E) and each enrolled participant will receive a single dose (Parts A and C) or multiple dose (Parts B, C and D) of either LY3839840 or placebo. Part E will study midazolam alone and with LY3839840. The study will last up to approximately 7 weeks for parts A, C (single dose cohort), 8 weeks for parts B, D and C (multiple dose cohort), and up to 3 weeks for Part E.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LY3839840	Administered orally.
DRUG	Placebo	Administered orally.
DRUG	Midazolam	Administered orally

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2023-12-01
• Last updated: 2025-06-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study