ClinicalTrials.gov record NCT07713758

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 65 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Phase 1, open-label study that gives one oral dose of repinatrabit to three groups: adults with moderate liver impairment, adults with severe kidney impairment (not on dialysis), and matched adults with normal liver and kidney function. The study measures drug levels over about one week and monitors safety for up to 14 days. Participants receive the dose while fasting.

What it is studying. This trial measures the pharmacokinetics of repinatrabit (unbound and total AUC and Cmax, including AUC0‑inf) after a single oral dose in adults with moderate hepatic impairment, adults with severe renal impairment, and matched adults with normal hepatic and renal function. It also collects short-term safety data.

What the researchers hope to learn. To determine whether moderate liver impairment or severe kidney impairment changes repinatrabit pharmacokinetics (unbound and total AUC0‑t, AUC0‑inf, and Cmax). To record treatment-emergent adverse events and potentially clinically relevant changes in labs, vital signs, physical exam, and ECG.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Repinatrabit

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive a single oral dose of repinatrabit while fasting on Day 1. They will have repeated blood samples from Day 1 through Day 8 to measure drug levels and laboratory safety tests, plus vital signs, physical examinations and 12‑lead ECGs; adverse events will be monitored through Day 14. Pregnancy testing is done before dosing and contraception/abstinence rules apply for those of childbearing potential. Reliable IV access will be needed for blood sampling; other routine safety assessments are performed per protocol.

How the study is structured. Phase 1, open-label, non-randomized, parallel-group drug study. Participants are placed into one of three groups (moderate hepatic impairment; severe renal impairment, not on dialysis; matched normal hepatic and renal function) and receive a single fasted oral tablet of repinatrabit on Day 1. Drug levels are measured through Day 8; safety assessments continue through Day 14.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jul 17, 2026
Primary completion
Feb 9, 2027 (estimated)
Study completion
Feb 15, 2027 (estimated)
Target enrollment
32 participants (estimated)
Last updated on registry
Aug 12, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Panax Clinical ResearchRecruiting

    Miami, Florida, 33014 · United States

Terms used on this page · explanations by MedicalUpdates.ai

informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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