A Study of TAK-279 in Adults With or Without Kidney Problems

Part of paid clinical trials in Miami, Florida.

Sponsor
Takeda
Study ID
NCT05992155
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers
  • Renal 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 kidney problems compared to participants without kidney 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 27, 2023
Status verified
Jun 2024
Primary completion
May 22, 2024
Completion
May 28, 2024

Study Design

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

Arms

  • Experimental: Cohort 1, Severe RI: TAK-279 50 mg
    Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
  • Experimental: Cohort 2, Normal Renal Function: TAK-279 50 mg
    Participants with normal renal function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
  • Experimental: Cohort 3, Moderate RI: TAK-279 50 mg
    Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study.

Primary Outcome Measure

Cmax: Maximum Observed Plasma Concentration for TAK-279 [ Time Frame: Predose to Day 10 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
Research by DesignChicagoIllinois60643-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLResearch by Design· Chicago, IL

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