Healthy VolunteersPhase 1NCT07712640
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 study testing BGB-58067 Tablet (F-01 Formulation) and BGB-58067 Tablet (F-02 Formulation) in people with Healthy Volunteers, run by BeOne Medicines at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BGB-58067 Tablet (F-01 Formulation) and BGB-58067 Tablet (F-02 Formulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Jul 2026to 1 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Cmax Clinical Research
Adelaide, South Australia, 5000
About this study
Official title: 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
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.
Read the detailed description
BGB-58067 works by blocking a protein in the body called PRMT5. Although all cells need PRMT5 to function normally, cancer cells depend on it more heavily for growth and survival. BGB-58067 has been designed to work in cancer cells that are missing a gene called MTAP (about 15% of all cancers). The aim of this approach is to target cancer cells and reduce harm to healthy tissues and reduce side-effects.
BeOne Medicines is developing a new tablet formulation of BGB-58067 (called F-02) which has minor changes in its composition compared to the existing formulation (called F-01). The study will be conducted in healthy adults.
The purpose of this study is to test whether the amount of BGB-58067 in the blood and the speed at which it enters the bloodstream after taking the new formulation are similar to those observed with the existing formulation.
Participants will each take 1dose of BGB-58067 orally (by mouth) with or without food during the treatment part of the study. Both participants and the study doctors will know what study drug participants are given.
About 32 participants in Australia will take part in this study. The overall time to participate in this study is around 12 weeks. Participants will stay at the clinic during the treatment part of the study and will have physical exams and blood tests.
- Conditions
- Healthy Volunteers
- Being tested
- BGB-58067 Tablet (F-01 Formulation), BGB-58067 Tablet (F-02 Formulation)
- Keywords
- Relative bioavailability, Food effect, Tablets formulation, Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-58067 Tablet (F-01 Formulation)Drug
Administered orally
BGB-58067 Tablet (F-02 Formulation)Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: BGB-58067 Tablet (F-01 Formulation); Drug: BGB-58067 Tablet (F-02 Formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Plasma Concentration-Time Curve from Time 0 Infinity (AUC0-inf) for BGB-58067
Measured: 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
Measured: Approximately 4 Days
Maximum Observed Plasma Concentration (Cmax) of BGB-58067
Measured: Approximately 4 Days
Time of the Maximum Observed Concentration (Tmax) for BGB-58067
Measured: Approximately 4 Days
Apparent Terminal Elimination Half-life (t1/2) for BGB-58067
Measured: Approximately 4 Days
Apparent Total Clearance from Plasma after Oral Administration (CL/F) for BGB-58067
Measured: Approximately 4 Days
Apparent Volume of Distribution at Steady State after Extravascular Administration (Vz/F) for BGB-58067
Measured: Approximately 4 Days
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs)
Number of participants with adverse events (AEs), abnormal vital signs, electrocardiogram (ECG) findings, clinically significant physical examination abnormalities, and clinically significant laboratory abnormalities.
Measured: Approximately 53 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start21 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712640
- Sponsor's protocol ID
- BGB-58067-103
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07712640
- Acronym / sponsor ID
- BGB-58067-103
- Conditions
- Healthy Volunteers
- Keywords
- Relative bioavailability, Food effect, Tablets formulation, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BGB-58067 works by blocking a protein in the body called PRMT5. Although all cells need PRMT5 to function normally, cancer cells depend on it more heavily for growth and survival. BGB-58067 has been designed to work in cancer cells that are missing a gene called MTAP (about 15% of all cancers). The aim of this approach is to target cancer cells and reduce harm to healthy tissues and reduce side-effects.
BeOne Medicines is developing a new tablet formulation of BGB-58067 (called F-02) which has minor changes in its composition compared to the existing formulation (called F-01). The study will be conducted in healthy adults.
The purpose of this study is to test whether the amount of BGB-58067 in the blood and the speed at which it enters the bloodstream after taking the new formulation are similar to those observed with the existing formulation.
Participants will each take 1dose of BGB-58067 orally (by mouth) with or without food during the treatment part of the study. Both participants and the study doctors will know what study drug participants are given.
About 32 participants in Australia will take part in this study. The overall time to participate in this study is around 12 weeks. Participants will stay at the clinic during the treatment part of the study and will have physical exams and blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: BGB-58067 Tablet (F-01 Formulation), Drug: BGB-58067 Tablet (F-02 Formulation)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. |
| Treatment Sequence 2 | Experimental | Drug: BGB-58067 Tablet (F-01 Formulation), Drug: BGB-58067 Tablet (F-02 Formulation)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. |
| Treatment Sequence 3 | Experimental | Drug: BGB-58067 Tablet (F-01 Formulation), Drug: BGB-58067 Tablet (F-02 Formulation)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. |
| Treatment Sequence 4 | Experimental | Drug: BGB-58067 Tablet (F-01 Formulation), Drug: BGB-58067 Tablet (F-02 Formulation)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-58067 Tablet (F-01 Formulation)Administered orally | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| BGB-58067 Tablet (F-02 Formulation)Administered orally | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
Area under the Plasma Concentration-Time Curve from Time 0 Infinity (AUC0-inf) for BGB-58067
Time frame: 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
Time frame: Approximately 4 Days
Maximum Observed Plasma Concentration (Cmax) of BGB-58067
Time frame: Approximately 4 Days
Time of the Maximum Observed Concentration (Tmax) for BGB-58067
Time frame: Approximately 4 Days
Apparent Terminal Elimination Half-life (t1/2) for BGB-58067
Time frame: Approximately 4 Days
Apparent Total Clearance from Plasma after Oral Administration (CL/F) for BGB-58067
Time frame: Approximately 4 Days
Apparent Volume of Distribution at Steady State after Extravascular Administration (Vz/F) for BGB-58067
Time frame: Approximately 4 Days
1 secondary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Approximately 53 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-58067 Tablet (F-01 Formulation) and BGB-58067 Tablet (F-02 Formulation) in people with Healthy Volunteers, run by BeOne Medicines at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Plasma Concentration-Time Curve from Time 0 Infinity (AUC0-inf) for BGB-58067 (time frame: Approximately 4 Days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.