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New drug interaction study launches for repinatrabit

NCT ID NCT07446400

Knowledge-focused Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This early-stage trial is testing how the experimental drug repinatrabit interacts with several common medications, including birth control pills, metformin, and methotrexate. The study involves 48 healthy volunteers and will measure drug levels in the blood to see if combining these drugs changes how they work. The goal is to gather safety and dosing information for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
repinatrabit (JNT517) oral tablet
What this could lead to
If successful, this study will help determine safe and effective dosing of repinatrabit when taken with other common medications.
What could go wrong
This is an early Phase 1 trial in healthy volunteers, not patients. It focuses on drug interactions, not treatment effects, so results may not predict real-world outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m\^2) (inclusive). 2. Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females. 3. In good health as determined by: 1. Medical history 2. Physical examination 3. ECG 4. Serum chemistry, urinalysis, hematology, and serology tests 4. Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact. 5. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial. Exclusion Criteria: 1. Female participants of childbearing potential. 2. Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only). 3. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy. 4. For Arm 3, participants who test positive for HLA haplotypes associated with carbamazepine-induced hypersensitivity (HLA-B\*15:02, HLA-A\*31:01, and HLA-B\*15:11). Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nucleus Network

    RECRUITING

    Melbourne, Victoria, 3004, Australia

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