A Phase I Study of LY3502970 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3502970; Drug: [14C]-LY3502970

• Registration Number: NCT06085482
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Study Start: 2023-10-19
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation
• Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
• Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study

Exclusion Criteria

• Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
• Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study
• Participants who regularly use known drugs of abuse or show positive findings on drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3502970 + [14C]-LY3502970	[14C]-LY3502970	Single dose of LY3502970 administered orally followed by single dose of \[¹⁴C\]-LY3502970 administered intravenously (IV)
LY3502970 + [14C]-LY3502970	LY3502970	Single dose of LY3502970 administered orally followed by single dose of \[¹⁴C\]-LY3502970 administered intravenously (IV)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Absolute bioavailability of LY3502970	Predose up to 16 days postdose	PK: Absolute bioavailability of LY3502970

Secondary Outcome Measures

Name	Time	Method
PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of Total Radioactivity	Predose up to 16 days postdose	PK: AUC \[0-∞\] of Total Radioactivity
PK: AUC [0-∞] of [14C]-LY3502970	Predose up to 16 days postdose	PK: AUC \[0-∞\] of \[14C\]-LY3502970
PK: Cmax of [14C]-LY3502970	Predose up to 16 days postdose	PK: Cmax of \[14C\]-LY3502970
PK: Cmax of LY3502970	Predose up to 16 days postdose	PK: Cmax of LY3502970
PK: AUC [0-∞] of LY3502970	Predose up to 16 days postdose	PK: AUC \[0-∞\] of LY3502970
PK: Maximum Concentration (Cmax) of Total Radioactivity	Predose up to 16 days postdose	PK: Cmax of Total Radioactivity

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Madison, Wisconsin, United States