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 | Not Yet Recruiting Phase 1

• 1 other identifier: BGB-58067-103
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

Relative bioavailability; Food effect; Tablets formulation; Healthy volunteer

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  Approximately 53 Days

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

Participants will receive a single oral dose of BGB-58067 F-01 tablet in fasted state, BGB-58067 F-02 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a high fat meal, and BGB-58067 F-02 tablet in the fed state with a low fat meal, with a 7-day washout between each dose.

Drug: BGB-58067 Tablet (F-01 Formulation); Drug: BGB-58067 Tablet (F-02 Formulation)

Treatment Sequence 2

EXPERIMENTAL

Participants will receive a single oral dose of BGB-58067 F-02 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a low fat meal, BGB-58067 F-01 tablet in fasted state, and BGB-58067 F-02 tablet in the fed state with a high fat meal, with a 7-day washout between each dose.

Drug: BGB-58067 Tablet (F-01 Formulation); Drug: BGB-58067 Tablet (F-02 Formulation)

Treatment Sequence 3

EXPERIMENTAL

Participants will receive a single oral dose of BGB-58067 F-02 tablet in fed state with low-fat meal, F-02 tablet in the fed state with a high fat meal, BGB-58067 F-02 tablet in fasted state, and BGB-58067 F-01 tablet in fasted state, with a 7-day washout between each dose.

Drug: BGB-58067 Tablet (F-01 Formulation); Drug: BGB-58067 Tablet (F-02 Formulation)

Treatment Sequence 4

EXPERIMENTAL

Participants will receive a single oral dose of BGB-58067 F-02 tablet in fed state with high-fat meal, BGB-58067 F-01 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a low fat meal, and BGB-58067 F-02 tablet in fasted state, with a 7-day washout between each dose.

Drug: BGB-58067 Tablet (F-01 Formulation); Drug: BGB-58067 Tablet (F-02 Formulation)

Interventions

BGB-58067 Tablet (F-01 Formulation) DRUG

Administered orally

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

BGB-58067 Tablet (F-02 Formulation) DRUG

Administered orally

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: See plan description
• Access Criteria: See plan description