A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573230
• Other study ID #: 18506
• Secondary ID: J2A-MC-GZGL
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: January 17, 2023

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Midazolam
Administered orally.
• LY3502970
Administered orally.
• Cyclosporine
Administered orally.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970	PK: AUC of LY3502970	Predose up to 96 hours postdose
Primary	PK: Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 96 hours postdose