Healthy VolunteersPhase 1NCT07446400
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
A Phase 1 study testing Repinatrabit, EE/NE and Metformin in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Repinatrabit, EE/NE and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Mar 2026to 7 Nov 2026
- Phase
- Phase 1
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m^2) (inclusive).
- Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.
- In good health as determined by:
- Medical history
- Physical examination
- ECG
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- Serum chemistry, urinalysis, hematology, and serology tests
- Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.
- 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.
Who cannot join
- Female participants of childbearing potential.
- Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
Gonan, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
About this study
Official title: A Phase 1, 4-arm, Open-label, Drug-drug Interaction Trial to Evaluate the Pharmacokinetics of Repinatrabit Oral Tablets When Co-administered With Ethinyl Estradiol/Norethindrone, Metformin, Carbamazepine, Rosuvastatin, and Methotrexate in Healthy Participants
The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- Repinatrabit, EE/NE, Metformin, Rosuvastatin, Methotrexate
- Keywords
- Phenylketonuria, Drug-Drug Interaction (DDI) study
- 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 JNT517
Oral tablet.
EE/NEDrug
Oral tablet.
MetforminDrug
Oral tablet.
RosuvastatinDrug
Oral tablet.
MethotrexateDrug
Oral tablet.
CarbamazepineDrug
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Repinatrabit + EE/NE | Experimental | Participants will first receive a single dose of EE/NE, orally, followed by repinatrabit in combination with EE/NE or alone, up to Day 18. Receives: Drug: Repinatrabit; Drug: EE/NE |
| Arm 2: Repinatrabit + (Metformin + Rosuvastatin) | Experimental | Participants will receive a single dose of metformin and rosuvastatin, orally, followed by repinatrabit in combination with metformin and rosuvastatin or alone, up to Day 9. Receives: Drug: Repinatrabit; Drug: Metformin; Drug: Rosuvastatin |
| Arm 3: Repinatrabit + Carbamazepine | Experimental | Participants will receive a single dose of repinatrabit, orally, followed by carbamazepine in combination with repinatrabit or alone, up to Day 15. Receives: Drug: Repinatrabit; Drug: Carbamazepine |
| Arm 4: Repinatrabit + Methotrexate | Experimental | Participants will receive a single dose of methotrexate, orally, followed by repinatrabit in combination with methotrexate or alone, up to Day 8. Receives: Drug: Repinatrabit; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Arms: Maximum Plasma Concentration (Cmax)
Cmax will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Observable Concentration at Time t (AUCt)
AUCt will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure.
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinfinity)
AUCinfinity will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure.
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
Secondary outcomes (8)
All Arms: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Arm 1: up to Day 25; Arm 2: up to Day 16; Arm 3: up to Day 22; Arm 4: up to Day 15
All Arms: Number of Participants With Potentially Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Tests
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Time to Maximum (Peak) Plasma Concentration (Tmax)
Tmax will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure.
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F)
CL/F will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure.
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Volume of Distribution Following Extravascular Administration (Vz/F)
Vz/F will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure.
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
All Arms: Terminal Phase Elimination Half-Life (t1/2,z)
The t1/2,z will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure.
Measured: Arm 1: up to Day 19; Arm 2: up to Day 10, Arm 3: up to Day 13; Arm 4: up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start31 Mar 2026
- Primary completion7 Nov 2026 (estimated)
- Study completion7 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446400
- Sponsor's protocol ID
- 359-201-00015
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 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.