A Study of Two Different Formulations of LY3502970 in Healthy Participants

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3502970


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3502970 (Formulation 1)<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Formulation 2)<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|

What is the study measuring?
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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 |