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Recruiting NCT07446400

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repinatrabit, EE/NE, Metformin, Rosuvastatin.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Repinatrabit
    Oral tablet.
  • Drug EE/NE
    Oral tablet.
  • Drug Metformin
    Oral tablet.
  • Drug Rosuvastatin
    Oral tablet.
  • Drug Methotrexate
    Oral tablet.
  • Drug Carbamazepine
    Oral tablet.

Primary outcome measures

  • All Arms: Maximum Plasma Concentration (Cmax) [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]
  • All Arms: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Observable Concentration at Time t (AUCt) [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]
  • All Arms: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinfinity) [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 outcome measures (8)
  • 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]
  • 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]
  • 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]
  • 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]
  • All Arms: Time to Maximum (Peak) Plasma Concentration (Tmax) [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]
  • All Arms: Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) [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]
  • All Arms: Volume of Distribution Following Extravascular Administration (Vz/F) [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]
  • All Arms: Terminal Phase Elimination Half-Life (t1/2,z) [Time frame: Arm 1: up to Day 19; Arm 2: up to Day 10, Arm 3: up to Day 13; Arm 4: up to Day 6]

Eligibility criteria

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Australia · 1 center
  • Nucleus Network — Melbourne

Identifiers

NCT: NCT07446400 · 359-201-00015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗