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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [¹⁴C]-LOXO-783; Drug: LOXO-783

• Registration Number: NCT06102512
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-23
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-26
• Primary Completion: 2023-12-23
• Study Completion: 2024-01-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
[¹⁴C]-LOXO-783 (Part 1)	[¹⁴C]-LOXO-783	Single dose of \[¹⁴C\]-LOXO-783 administered orally
LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)	LOXO-783	Single dose of LOXO-783 administered orally followed by single dose of \[¹⁴C\]-LOXO-783 administered intravenously (IV)
LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)	[¹⁴C]-LOXO-783	Single dose of LOXO-783 administered orally followed by single dose of \[¹⁴C\]-LOXO-783 administered intravenously (IV)

Primary Outcome Measures

Name	Time	Method
PK: Absolute Bioavailability (F) of LOXO-783	Predose on day 1 up to postdose on day 9 (Part 2)	PK: F of LOXO-783
Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)	Predose on day 1 up to postdose on day 21 (Part 1)	PK: Feur
PK: Cumulative Feur	Predose on day 1 up to postdose on day 21 (Part 1)	PK: Cumulative Feur
PK: Fraction of Dose Excreted in Expired Air (Feair)	Predose on day 1 up to postdose on day 21 (Part 1)	PK: Feair
PK: Fraction of Dose Excreted in Feces (Fefeces)	Predose on day 1 up to postdose on day 21 (Part 1)	PK: Fefeces
PK: Cumulative Fefeces	Predose on day 1 up to postdose on day 21 (Part 1)	PK: Cumulative Fefeces

Trial Locations

Locations (1)

Fortrea Clinical Research; 🇺🇸 Madison, Wisconsin, United States