A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

NCT05573230 | Completed Phase 1

• 2 other identifiers: 18506J2A-MC-GZGL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Midazolam + LY3502970

EXPERIMENTAL

Midazolam administered orally followed by LY3502970 given orally.

Drug: Midazolam; Drug: LY3502970

Cyclosporine + Midazolam + LY3502970

EXPERIMENTAL

Cyclosporine administered in combination with midazolam and LY3502970 given orally.

Drug: Midazolam; Drug: LY3502970; Drug: Cyclosporine

Interventions

Midazolam DRUG

Administered orally.

Cyclosporine + Midazolam + LY3502970; Midazolam + LY3502970

LY3502970 DRUG

Administered orally.

Cyclosporine + Midazolam + LY3502970; Midazolam + LY3502970

Cyclosporine DRUG

Administered orally.

Cyclosporine + Midazolam + LY3502970

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

Midazolam; orforglipron; Cyclosporine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 10, 2022
• Study Start: October 17, 2022
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)