A Study of TAK-279 in Adults With or Without Liver Damage

Part of paid clinical trials in Miami, Florida.

Sponsor
Takeda
Study ID
NCT05976321
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. The participants will need to stay at the clinic for 11 days.

Key Dates

Start date
Sep 22, 2023
Status verified
Aug 2024
Primary completion
Apr 15, 2024
Completion
Apr 15, 2024

Study Design

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

Arms

  • Experimental: Cohort 1, Moderate HI: TAK-279 50 mg
    Participants with moderate HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
  • Experimental: Cohort 2, Normal Hepatic Function: TAK-279 50 mg
    Participants with normal hepatic function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. Based on an evaluation of the results from Part A, additional participants with normal hepatic function may be enrolled in Part B of the study.
  • Experimental: Cohort 3, Mild/Severe HI: TAK-279 50 mg
    Participants with mild/severe HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study based on an evaluation of the results from Part A.

Primary Outcome Measure

Cmax: Maximum Observed Plasma Concentration for TAK-279 [ Time Frame: Predose and at multiple time points post dose from Days 1 to 10 ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33146-
Orlando Clinical Research CenterOrlandoFlorida32809-
American Research Corporation - Texas Liver InstituteSan AntonioTexas78215-
Pinnacle Clinical Research - San AntonioSan AntonioTexas78229-

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLAmerican Research Corporation - Texas Liver Institute· San Antonio, TXPinnacle Clinical Research - San Antonio· San Antonio, TX

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