A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Eli Lilly and Company
Study ID
NCT06111521
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • LY3537982 — DRUG
    Administered orally
  • Digoxin — DRUG
    Administered orally
  • Rosuvastatin — DRUG
    Administered orally
  • Midazolam — DRUG
    Administered orally
  • Midazolam — DRUG
    Administered IV

Study Details

The main purpose of this study is to evaluate the effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein \[P-gp\] substrate), rosuvastatin (a breast cancer resistance protein \[BCRP)\] substrate), and midazolam (a substrate of Cytochrome P450 3A4 \[CYP3A4\]) in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982 with or without single doses of digoxin, rosuvastatin, and midazolam. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 23 and 11 days for part 1 and part 2, respectively, not including screening.

Key Dates

Start date
Oct 27, 2023
Status verified
Nov 2024
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3537982 + Digoxin & Rosuvastatin (Part 1)
    Single oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally
  • Experimental: LY3537982 + Midazolam (Part 2)
    Single doses of midazolam administered either orally or intravenously (IV) with or without multiple doses of LY3537982 administered orally

Primary Outcome Measure

Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 [ Time Frame: Predose on day 11 up to day 17 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON Early Clinical & Bioanalytical SolutionsSalt Lake CityUtah84124-

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By research site
ICON Early Clinical & Bioanalytical Solutions· Salt Lake City, UT

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