A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants
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 |
---|---|---|
Phase 1 |
Study Design
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.
|
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
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.- 18506
- J2A-MC-GZGL