Clinical Trials in Australia / NCT07712640
Recruiting
Phase 1
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
NCT07712640 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Healthy Volunteers
Investigational drug(s) / intervention(s)
BGB-58067 Tablet (F-01 Formulation): Administered orally
BGB-58067 Tablet (F-02 Formulation): Administered orally
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Area under the Plasma Concentration-Time Curve from Time 0 Infinity (AUC0-inf) for BGB-58067 — Approximately 4 Days
- Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t last) for BGB-58067 — Approximately 4 Days
- Maximum Observed Plasma Concentration (Cmax) of BGB-58067 — Approximately 4 Days
- Time of the Maximum Observed Concentration (Tmax) for BGB-58067 — Approximately 4 Days
- Apparent Terminal Elimination Half-life (t1/2) for BGB-58067 — Approximately 4 Days
- Apparent Total Clearance from Plasma after Oral Administration (CL/F) for BGB-58067 — Approximately 4 Days
- Apparent Volume of Distribution at Steady State after Extravascular Administration (Vz/F) for BGB-58067 — Approximately 4 Days
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Cmax Clinical Research | Adelaide | South Australia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07712640 on ClinicalTrials.gov ↗ ← All trials in Australia