A Phase I Study of LY3502970 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06085482
• Other study ID #: 18596
• Secondary ID: J2A-MC-GZGO
• Status: Completed
• Phase: Phase 1
• Start date: October 19, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3502970
Administered orally
• [14C]-LY3502970
Administered IV

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Absolute bioavailability of LY3502970	PK: Absolute bioavailability of LY3502970	Predose up to 16 days postdose
Secondary	PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-8]) of Total Radioactivity	PK: AUC [0-8] of Total Radioactivity	Predose up to 16 days postdose
Secondary	PK: AUC [0-8] of [14C]-LY3502970	PK: AUC [0-8] of [14C]-LY3502970	Predose up to 16 days postdose
Secondary	PK: AUC [0-8] of LY3502970	PK: AUC [0-8] of LY3502970	Predose up to 16 days postdose
Secondary	PK: Maximum Concentration (Cmax) of Total Radioactivity	PK: Cmax of Total Radioactivity	Predose up to 16 days postdose
Secondary	PK: Cmax of [14C]-LY3502970	PK: Cmax of [14C]-LY3502970	Predose up to 16 days postdose
Secondary	PK: Cmax of LY3502970	PK: Cmax of LY3502970	Predose up to 16 days postdose