A Multiple-Dose Study 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 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.

Official Title
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A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted 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 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.

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 (Fed)<br>LY3502970 administered orally to participants who are in a fed state. | Drug: LY3502970<br>* Administered Orally.<br>|
| Experimental: LY3502970 (Fasted)<br>LY3502970 administered orally to participants who are in a fasted state. | 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 | Predose up to 41 days postdose | 
| PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970 | PK: AUC0-24 of LY3502970 | Predose up to 41 days postdose | 
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 | PK: Tmax of LY3502970 | Predose up to 41 days postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food, Food Effect