A Study of Two Different Formulations of LY3502970 in Healthy Participants

A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3502970 (Formulation 1); LY3502970 administered orally.	Drug: LY3502970; Administered orally.
EXPERIMENTAL: LY3502970 (Formulation 2); LY3502970 administered orally.	Drug: LY3502970; Administered orally.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2022
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ACTUAL): September 1, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 15, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 17785; J2A-MC-GZGH (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No