Understanding how two tablet formats and food affect BGB-58067 in healthy adults

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 early-phase study compares two tablet formulations of BGB-58067 (F-01 and F-02) to see if their blood levels and absorption rates are similar. It also assesses how taking the drug with or without food influences pharmacokinetics. The trial is conducted in healthy adults and includes a cross-condition design where each participant receives both formulations under different food conditions. The study aims to inform formulation choice and dosing considerations for future cancer-focused research. Participants will stay in a clinic for the treatment period, with monitoring through exams and blood tests.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must be 18 to 65 years of age, inclusive, at the time of signing the ICF.
* Participants who are overtly healthy, as determined by the investigator or delegate through medical evaluation
* Female participants must be of non-childbearing potential. Note: A woman is considered 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 90 days after the last dose of BGB-58067.An additional highly effective method of birth control must be used for the duration of the study and for 90 days 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:

* 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 allowed unless it is active (ie, No clinically meaningful allergy symptoms at screening and pre-dose, no requirement for pharmacologic therapy, and stable condition without anticipated flare during the PK assessment period).
* History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric (including SIB) disorder, or severe cutaneous adverse reactions such as Stevens-Johnson Syndrome, as judged by the investigator or delegate.
* Participants with a history of cholecystectomy or gall stones.

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.