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

Eli Lilly and Company1 site in 1 country16 target enrollmentOctober 23, 2023

ConditionsHealthy

Interventions[¹⁴C]-LOXO-783 LOXO-783

Drugs[¹⁴C]-LOXO-783 LOXO-783

Overview

Phase: Phase 1
Intervention: [¹⁴C]-LOXO-783
Conditions: Healthy
Sponsor: Eli Lilly and Company
Enrollment: 16
Locations: 1
Primary Endpoint: PK: Fraction of Dose Excreted in Expired Air (Feair)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 23, 2023

End Date

January 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator
•Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
•Female participants of non-childbearing potential and male participants who follow standard contraceptive methods

Exclusion Criteria

•History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
•Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
•History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator