A Research Study on Etavopivat in Participants With and Without Liver Disease

Part of paid clinical trials in Orlando, Florida.

Sponsor
Novo Nordisk A/S
Study ID
NCT06336018
Phase
PHASE1
Status
Completed

Conditions

  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etavopivat — DRUG
    Participants will receive a single dose of etavopivat orally.

Study Details

The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days.

Key Dates

Start date
May 20, 2024
Status verified
Oct 2025
Primary completion
Aug 1, 2025
Completion
Aug 1, 2025

Study Design

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

Arms

  • Experimental: Mild hepatic impairment: Etavopivat dose 2
    Participants will receive a single dose of oral etavopivat.
  • Experimental: Moderate hepatic impairment: Etavopivat dose 2
    Participants will receive a single dose of oral etavopivat.
  • Experimental: Healthy matched controls: Etavopivat dose 2
    Participants will receive a single dose of oral etavopivat.
  • Experimental: Severe hepatic impairment: Etavopivat dose 1
    Participants will receive a single dose of oral etavopivat.
  • Experimental: Healthy matched controls: Etavopivat dose 1
    Participants will receive a single dose of oral etavopivat.

Primary Outcome Measure

Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat) [ Time Frame: From IMP administration on day 1 to completion of the end of study visit (day 9) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Orlando Clinical Research CenterOrlandoFlorida32806-
Orlando Clinical Research CenterOrlandoFlorida32809-
Amer. Rrsch Corp-TX Liver InstSan AntonioTexas78215-

Find similar trials in Orlando, FL

By research site
Orlando Clinical Research Center· Orlando, FLAmer. Rrsch Corp-TX Liver Inst· San Antonio, TX

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