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A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m²) (inclusive).

Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.

Medical history

Physical examination

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repinatrabit

    Drug

    Oral tablet.

  • EE/NE

    Drug

    Oral tablet.

  • Metformin

    Drug

    Oral tablet.

  • Rosuvastatin

    Drug

    Oral tablet.

  • Methotrexate

    Drug

    Oral tablet.

  • Carbamazepine

    Drug

    Oral tablet.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Arm 1: Repinatrabit + EE/NEExperimental treatment 2 interventions
Group B: Arm 2: Repinatrabit + (Metformin + Rosuvastatin)Experimental treatment 3 interventions
Group C: Arm 3: Repinatrabit + CarbamazepineExperimental treatment 2 interventions
Group D: Arm 4: Repinatrabit + MethotrexateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
2

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.

Time frame
Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
3

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.

Time frame
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

1

All Arms: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame
Arm 1: up to Day 25; Arm 2: up to Day 16; Arm 3: up to Day 22; Arm 4: up to Day 15
2

All Arms: Number of Participants With Potentially Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Tests

Time frame
Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
3

All Arms: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs

Time frame
Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
4

All Arms: Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests

Time frame
Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead sponsor

Source ClinicalTrials.gov
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