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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• All Arms: Maximum Plasma Concentration (Cmax) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9]

Вторичные конечные точки (8)

• All Arms: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Arm 1: up to Day 19; Arm 2: up to Day 10, Arm 3: up to Day 13; Arm 4: up to Day 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Австралия · 1 центр

• Nucleus Network — Melbourne

Идентификаторы

NCT: NCT07446400 · 359-201-00015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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