A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.

Official Title
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A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Cyclosporine on the Pharmacokinetics of LY3502970 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Midazolam
* Drug: LY3502970
* Drug: Cyclosporine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²) Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Exclusion Criteria: Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs Participants who regularly use known drugs of abuse Women who are lactating and who are of child-bearing potential Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam + LY3502970<br>Midazolam administered orally followed by LY3502970 given orally. | Drug: Midazolam<br>* Administered orally.<br>Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: Cyclosporine + Midazolam + LY3502970<br>Cyclosporine administered in combination with midazolam and LY3502970 given orally. | Drug: Midazolam<br>* Administered orally.<br>Drug: LY3502970<br>* Administered orally.<br>Drug: Cyclosporine<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | PK: AUC of LY3502970 | Predose up to 96 hours postdose | 
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 96 hours postdose |