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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m²) (inclusive).

Able to provide written, informed consent.

Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.

Otherwise be in generally good health.

Disqualifiers

Participants who are breastfeeding.

Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).

Participants with international normalized ratio (INR) greater than (>) 2.3. Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.

Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repinatrabit

    Drug

    Oral tablet

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Group 1: Moderate Hepatic ImpairmentExperimental treatment 1 intervention
Group B: Group 2: Severe Renal ImpairmentExperimental treatment 1 intervention
Group C: Group 3: Matched Normal Hepatic and Renal FunctionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit

Time frame
From Day 1 to Day 8
3

Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit

Time frame
From Day 1 to Day 8

Secondary outcomes

1

All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)

Time frame
Up to Day 14
2

All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results

Time frame
Up to Day 8
3

All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs

Time frame
Up to Day 8
4

All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings

Time frame
Up to Day 8

Other outcomes

Sponsors and contacts

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