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NCT07713758 · Otsuka Pharmaceutical Development & Commercialization, Inc.

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

What this study is about

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.

View original scientific description

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.

Interventions

DRUG

Repinatrabit

Oral tablet

Primary outcome measures

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

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

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

Time frame: From Day 1 to Day 8

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m\^2) (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.
  • Additional criteria for Group 1: i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B). ii. Have relatively stable hepatic function for the duration of the study as determined by the investigator and liver function test at the time of screening or stable hepatic function 1 year prior to screening. iii. Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.
  • Additional criteria for Group 2: i. Have estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (eGFRCKD-EPI) lesser than (\<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) indicating severe renal impairment. ii. Not currently be on dialysis. iii. Have relatively stable renal function as determined by eGFRCKD-EPI. 7) Additional criteria for Group 3: i. eGFRCKD-EPI greater than or equal to (≥) 90 mL/min/1.73 m\^2 indicating normal renal function. ii. Have liver enzymes within normal limits.

Exclusion criteria

  • 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.
  • A history of difficulty in obtaining intravenous access.
  • The donation of blood or plasma \> 250 milliliters (mL) within 30 days prior to screening or received \> 50 mL of blood or plasma within 30 days prior to screening.
  • Participants who have taken an investigational drug within 30 days prior to screening.
  • Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).
  • Any participant who, in the opinion of the investigator, should not participate in the trial.
  • Previous exposure to repinatrabit.
  • Additional criteria for Group 1: History of serious mental disorder including participants who have greater than Grade 1 encephalopathy as assessed by the Child-Pugh score and/or the investigator's judgment.
  • Additional criteria for Group 2: i) Participants that have undergone a renal transplant. ii) Participants expected to require dialysis within 45 days. iii) Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at screening or on Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.
  • Additional criteria for Group 3: History of or current hepatitis, or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC). Note: Other protocol-specified inclusion/exclusion criteria may apply.

Where

  • Miami, Florida

Related conditions & keywords

Phenylketonuria

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations

📊
1 of 32 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Miami

Florida

Location available
View Miami location page

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Phenylketonuria Treatment in Miami?

Join others in Florida exploring innovative treatment options through clinical research

Phenylketonuria Treatment Options in Miami, Florida

If you're searching for Phenylketonuria treatment in Miami, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Miami and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Phenylketonuria. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Florida
Now Enrolling
Up to 32 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Phenylketonuria?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Phenylketonuria

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Phenylketonuria Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07713758. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.