A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cyclosporine; Drug: Midazolam; Drug: LY3502970

Study type: Interventional

Funder types: Industry

Identifiers

NCT05573230

J2A-MC-GZGL (Other Identifier)

18506

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Midazolam + LY3502970

Experimental group

Description:

Midazolam administered orally followed by LY3502970 given orally.

Treatment:

Drug: LY3502970

Drug: Midazolam

Cyclosporine + Midazolam + LY3502970

Experimental group

Description:

Cyclosporine administered in combination with midazolam and LY3502970 given orally.

Treatment:

Drug: Cyclosporine

Drug: LY3502970

Drug: Midazolam