A Study of Two Different Formulations of LY3502970 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3502970

• Registration Number: NCT05341089
• 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 when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Study Start: 2022-05-17
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2022-09-15
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation
• Participants who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
• Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)
• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria

• Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening
• Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening
• Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
• Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing
• Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. 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, or both. 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, or all. 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 (Formulation 1)	LY3502970	LY3502970 administered orally.
LY3502970 (Formulation 2)	LY3502970	LY3502970 administered orally.

Primary Outcome Measures

Name	Time	Method
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	Pre-dose on Day 1 up to 39 days post-dose	PK: Tmax of LY3502970
PK: Area Under the Plasma Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LY3502970	Pre-dose on Day 1 up to 39 days post-dose	PK: AUC0-24 of LY3502970
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970	Pre-dose on Day 1 up to 39 days post-dose	PK: Cmax of LY3502970

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore