A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT05860933
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • LY3537982 — DRUG
    Administered orally.
  • Itraconazole — DRUG
    Administered orally.
  • Carbamazepine — DRUG
    Administered orally.

Study Details

The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.

Key Dates

Start date
May 8, 2023
Status verified
Nov 2024
Primary completion
Aug 28, 2023
Completion
Aug 28, 2023

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3537982 + Itraconazole (Part 1)
    LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.
  • Experimental: LY3537982 + Carbamazepine (Part 2)
    LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole [ Time Frame: Predose on day 1 up to 72 hours postdose on day 9 ]

Locations (2)

FacilityCityStateZIPSite coordinators
ICON Early Development ServicesSan AntonioTexas78209-
ICON Early Development ServicesSalt Lake CityUtah84124-

Find similar trials in San Antonio, TX

By research site
ICON Early Development Services· San Antonio, TXICON Early Development Services· Salt Lake City, UT

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