How the drug BGB-58067 behaves when taken with phenytoin or itraconazole

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study in healthy volunteers investigates how the metabolism of BGB-58067 is affected when co-administered with two medicines that alter the CYP3A enzyme. Part A examines co-treatment with phenytoin to see if increased enzyme activity changes BGB-58067 levels, while Part B uses itraconazole to assess the impact of enzyme inhibition. The trial involves pharmacokinetic measurements and safety assessments to understand potential drug-drug interactions. It is conducted at Cmax Clinical Research in Adelaide under BeOne Medicines as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Cmax Clinical Research
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.