A Multiple-Dose Study of LY3502970 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3502970

• Registration Number: NCT05110794
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study Start: 2021-11-05
• Study First Posted: 2021-11-08
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2022-06-15
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation.
• Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Exclusion Criteria

• Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
• Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
• Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
• Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.
• Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3502970 (Fed)	LY3502970	LY3502970 administered orally to participants who are in a fed state.
LY3502970 (Fasted)	LY3502970	LY3502970 administered orally to participants who are in a fasted state.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970	Predose up to 41 days postdose	PK: Cmax of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	Predose up to 41 days postdose	PK: Tmax of LY3502970
PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970	Predose up to 41 days postdose	PK: AUC0-24 of LY3502970

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore