A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05573230

Collaborator

(none)

Enrollment

Location

Arms

2.2

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Midazolam Drug: LY3502970 Drug: Cyclosporine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

Dec 23, 2022

Anticipated Study Completion Date :

Dec 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Midazolam + LY3502970 Midazolam administered orally followed by LY3502970 given orally.	Drug: Midazolam Administered orally. Drug: LY3502970 Administered orally.
Experimental: Cyclosporine + Midazolam + LY3502970 Cyclosporine administered in combination with midazolam and LY3502970 given orally.	Drug: Midazolam Administered orally. Drug: LY3502970 Administered orally. Drug: Cyclosporine Administered orally.

Arm

Intervention/Treatment

Experimental: Midazolam + LY3502970

Midazolam administered orally followed by LY3502970 given orally.

Drug: Midazolam

Administered orally.

Drug: LY3502970

Administered orally.

Experimental: Cyclosporine + Midazolam + LY3502970

Cyclosporine administered in combination with midazolam and LY3502970 given orally.

Drug: Midazolam

Administered orally.

Drug: LY3502970

Administered orally.

Drug: Cyclosporine

Administered orally.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lilly Centre for Clinical Pharmacology	Singapore		Singapore	138623

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05573230

Other Study ID Numbers:

18506
J2A-MC-GZGL

First Posted:

Oct 10, 2022

Last Update Posted:

Nov 28, 2022

Last Verified:

Nov 15, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cyclosporine

Midazolam

Cyclosporins

Study Results

No Results Posted as of Nov 28, 2022