A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function

Part of paid clinical trials in Miami, Florida.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07713758
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Repinatrabit — DRUG
    Oral tablet

Study Details

This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver function.

Key Dates

First listed
Jul 20, 2026
Start date
Jul 17, 2026
Status verified
Aug 2026
Primary completion
Feb 9, 2027
Completion
Feb 15, 2027

Study Design

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

Arms

  • Experimental: Group 1: Moderate Hepatic Impairment
    Participants with moderate hepatic impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
  • Experimental: Group 2: Severe Renal Impairment
    Participants with severe renal impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
  • Experimental: Group 3: Matched Normal Hepatic and Renal Function
    Participants matched by age, weight, and sex with normal hepatic and renal function will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.

Primary Outcome Measure

Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve Calculated to the Last Observable Concentration at Time t (AUC0-t) of Repinatrabit [ Time Frame: From Day 1 to Day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Panax Clinical ResearchMiamiFlorida33014-

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By research site
Panax Clinical Research· Miami, FL

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