An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

Part of paid clinical trials in Lake Forest, California.

Sponsor
Alumis Inc
Study ID
NCT06952634
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • envudeucitinib — DRUG
    Single oral dose of ESK-001 in participants from all cohorts

Study Details

This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.

Key Dates

Start date
Apr 29, 2025
Status verified
May 2026
Primary completion
Mar 24, 2026
Completion
Mar 24, 2026

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy Volunteer
    Up to 24 healthy volunteer participants will receive a single dose of ESK-001
  • Experimental: Mild Hepatic Impairment
    8 participants with mild hepatic impairment will receive a single dose of ESK-001
  • Experimental: Moderate Hepatic Impairment
    8 participants with moderate hepatic impairment will receive a single dose of ESK-001
  • Experimental: Severe Hepatic Impairment
    8 participants with severe hepatic impairment will receive a single dose of ESK-001

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: 48 hours ]

Locations (4)

FacilityCityStateZIPSite coordinators
Orange County Research CenterLake ForestCalifornia92630-
Panax Clinical ResearchMiami LakesFlorida33104-
Orlando Clinical Research CenterOrlandoFlorida32809-
Alliance for Multispecialty ResearchKnoxvilleTennessee37920-

Find similar trials in Lake Forest, CA

By research site
Orange County Research Center· Lake Forest, CAPanax Clinical Research· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLAlliance for Multispecialty Research· Knoxville, TN

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