A Phase I Study of LY3502970 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06085482

Collaborator

(none)

Enrollment

Location

Arm

1.9

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3502970 Drug: [14C]-LY3502970	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Oct 19, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3502970 + [14C]-LY3502970 Single dose of LY3502970 administered orally followed by single dose of [¹⁴C]-LY3502970 administered intravenously (IV)	Drug: LY3502970 Administered orally Drug: [14C]-LY3502970 Administered IV

Arm

Intervention/Treatment

Experimental: LY3502970 + [14C]-LY3502970

Single dose of LY3502970 administered orally followed by single dose of [¹⁴C]-LY3502970 administered intravenously (IV)

Drug: LY3502970

Administered orally

Drug: [14C]-LY3502970

Administered IV

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Absolute bioavailability of LY3502970 [Predose up to 16 days postdose]
PK: Absolute bioavailability of LY3502970

Secondary Outcome Measures

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: 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Inc	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT06085482

Other Study ID Numbers:

18596
J2A-MC-GZGO

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 17, 2023