A Study of LY3502970 in Participants With Impaired and Normal Liver Function

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05882032
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Hepatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • LY3502970 — DRUG
    Administered orally.

Study Details

The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of LY3502970 will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.

Key Dates

Start date
Jun 13, 2023
Status verified
Apr 2026
Primary completion
Nov 18, 2024
Completion
Nov 18, 2024

Study Design

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

Arms

  • Experimental: 1 mg LY3502970 (Control: Normal Hepatic Function)
    Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1.
  • Experimental: 1 mg LY3502970 (Mild Hepatic Impairment)
    Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
  • Experimental: 1 mg LY3502970 (Moderate Hepatic Impairment)
    Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
  • Experimental: 1 mg LY3502970 (Severe Hepatic Impairment)
    Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970 [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
Pinnacle Clinical ResearchSan AntonioTexas78229-
Texas Liver InstituteSan AntonioTexas78215-

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