A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants

Официальное название

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants

Обзор

This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines. BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream. In this study, we will give BGB-58067 together with two commonly used medicines: * Part A: Phenytoin (inducer), which can increase the production of the enzyme, and * Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.

Вмешательства

• Препарат BGB-58067
  Administered orally
• Препарат Phenytoin
  Administered orally
• Препарат Itraconazole
  Administered orally

Первичные конечные точки

• Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]
• Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]
• Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]
• Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]
• Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]
• Part A and Part B: Apparent Total Clearance (CL/F) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]
• Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-58067 [Срок оценки: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8]

Вторичные конечные точки (1)

• Part A and Part B: Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 30 days]

Критерии участия

Критерии включения

• Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• Participants must be willing and able to comply with all study requirements.
• Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign measurements,12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the investigator, with additional requirements as follows:

a. Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 inclusive.

• Female participants must be of no childbearing potential. Note: A female participant is considered of childbearing potential (ie, fertile, following menarche, and until becoming postmenopausal) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
• Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 3 months after the last dose of BGB-58067. An additional highly effective method of birth control is highly recommended for the duration of the study and for 3 months after the last dose of BGB-58067. A sterile man is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Men with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile for purposes of this study

Критерии исключения

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• Presence or history of relevant seasonal allergies requiring treatment, drug and/or food allergies (ie, allergy to any study drug or excipients, or any significant food allergy that could preclude a standard diet in the study site). Hay fever is not an exclusion criterion unless it is active
• Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria
• History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological or psychiatric (including suicidal ideation or behavior) disorder; or severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), as judged by the investigator.
• Participants with a history of cholecystectomy or gall stones
• Poor venous access that limits phlebotomy
• Positive highly sensitive serum pregnancy test at screening, and positive highly sensitive urine test at admission.

Note: Other protocol-defined 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

Лечение

Центры проведения

Австралия · 1 центр

• Cmax Clinical Research — Adelaide

Идентификаторы

NCT: NCT07590102 · BGB-58067-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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