A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Midazolam; Drug: LY3502970; Drug: Cyclosporine

• Registration Number: NCT05573230
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Study Start: 2022-10-17
• Primary Completion: 2023-01-17
• Study Completion: 2023-01-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Midazolam + LY3502970	LY3502970	Midazolam administered orally followed by LY3502970 given orally.
Cyclosporine + Midazolam + LY3502970	LY3502970	Cyclosporine administered in combination with midazolam and LY3502970 given orally.
Midazolam + LY3502970	Midazolam	Midazolam administered orally followed by LY3502970 given orally.
Cyclosporine + Midazolam + LY3502970	Midazolam	Cyclosporine administered in combination with midazolam and LY3502970 given orally.
Cyclosporine + Midazolam + LY3502970	Cyclosporine	Cyclosporine administered in combination with midazolam and LY3502970 given orally.

Primary Outcome Measures

Name	Time	Method
PK: Maximum Observed Concentration (Cmax) of LY3502970	Predose up to 96 hours postdose	PK: Cmax of LY3502970
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970	Predose up to 96 hours postdose	PK: AUC of LY3502970

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore