A Phase I Study of LY3502970 in Healthy Participants
A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2024
CompletedMarch 25, 2024
March 1, 2024
3 months
October 10, 2023
March 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (PK): Absolute bioavailability of LY3502970
PK: Absolute bioavailability of LY3502970
Predose up to 16 days postdose
Secondary Outcomes (6)
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 [14C]-LY3502970
Predose up to 16 days postdose
PK: AUC [0-∞] of LY3502970
Predose up to 16 days postdose
PK: Maximum Concentration (Cmax) of Total Radioactivity
Predose up to 16 days postdose
PK: Cmax of [14C]-LY3502970
Predose up to 16 days postdose
- +1 more secondary outcomes
Study Arms (1)
LY3502970 + [14C]-LY3502970
EXPERIMENTALSingle dose of LY3502970 administered orally followed by single dose of \[¹⁴C\]-LY3502970 administered intravenously (IV)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Inc
Madison, Wisconsin, 53704, United States
MeSH Terms
Interventions
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2023
First Posted
October 17, 2023
Study Start
October 19, 2023
Primary Completion
January 5, 2024
Study Completion
January 5, 2024
Last Updated
March 25, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share