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PhenylketonuriaPhase 1NCT07713758

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

A Phase 1 study testing Repinatrabit in people with Phenylketonuria, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Phenylketonuria
What is being tested?
Repinatrabit
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
17 Jul 2026to 15 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • Have moderate hepatic impairment determined using Child-Pugh classification (Class B).
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  • 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.
  • Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.
  • Additional criteria for Group 2:
  • 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.
  • 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.
  • Have liver enzymes within normal limits.

Who cannot join

  • 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.
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  • 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:
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Otsuka Call Center contact

844-687-8522

Otsuka-ProfessionalServices@otsuka-us.com

United States1 site, 1 recruiting

  • Panax Clinical Research

    Miami, Florida, 33014

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Conditions
Phenylketonuria
Being tested
Repinatrabit
Medical subject headings
Phenylketonurias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RepinatrabitDrug

    Also called JNT-517

    Oral tablet

Study groups in NCT07713758
Study groupRoleWhat they receive
Group 1: Moderate Hepatic ImpairmentExperimentalParticipants with moderate hepatic impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
Receives: Drug: Repinatrabit
Group 2: Severe Renal ImpairmentExperimentalParticipants with severe renal impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
Receives: Drug: Repinatrabit
Group 3: Matched Normal Hepatic and Renal FunctionExperimentalParticipants 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.
Receives: Drug: Repinatrabit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: From Day 1 to Day 8

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

    Measured: From Day 1 to Day 8

Secondary outcomes (5)

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

    Measured: Up to Day 14

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

    Measured: Up to Day 8

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

    Measured: Up to Day 8

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

    Measured: Up to Day 8

  5. All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results

    Measured: Up to Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start17 Jul 2026
  3. Primary completion9 Feb 2027 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07713758
Sponsor's protocol ID
359-201-00009
Status last verified
Aug 2026
First submitted
15 Jul 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Repinatrabit in people with Phenylketonuria, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Otsuka Call Center (844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07713758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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