A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT05573230
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Midazolam — DRUG
    Administered orally.
  • LY3502970 — DRUG
    Administered orally.
  • Cyclosporine — DRUG
    Administered orally.

Study Details

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.

Key Dates

Start date
Oct 17, 2022
Status verified
Apr 2026
Primary completion
Jan 17, 2023
Completion
Jan 17, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Midazolam + LY3502970
    Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1.
  • Experimental: Cyclosporine + Midazolam + LY3502970
    Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose ]

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