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NCT07712640From ClinicalTrials.govRecruiting

A Study to Investigate the Relative Bioavailability of 2 Tablet Formulations and the Effect of Food on the Pharmacokinetics of BGB-58067 in Healthy Participants

A Phase 1, Single Dose, Open-label, Randomized 4-Period, 4-Sequence Crossover Study to Assess the Relative Bioavailability of Two Tablet Formulations of BGB-58067 and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-58067 Administered Simultaneously to Healthy Adult Participants

  • Healthy Volunteers

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
BeOne Medicines
Enrolment target
32
Started
21 July 2026
Main results due
1 July 2027
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 65 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

This study is being done to understand how the body processes 2 different tablet formulations of the study drug (BGB-58067) and how food intake influences the processing of the study drug by the body.

Study sites(1)

  • Cmax Clinical Research

    Adelaide, South Australia, Australia

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07712640. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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