NCT06102512

A Study of [14C]-LOXO-783 in Healthy Adult Participants

A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult 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 how much of the study drug, the radioactive substance 14C incorporated LOXO-783 (\[¹⁴C\]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and \[¹⁴C\]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[¹⁴C]-LOXO-783	Administered orally
DRUG	LOXO-783	Administered orally
DRUG	[¹⁴C]-LOXO-783	Administered IV

Timeline

• Start date: 2023-10-23
• Primary completion: 2023-12-23
• Completion: 2024-01-17
• First posted: 2023-10-26
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study