Healthy Volunteers
Conditions
Keywords
Relative bioavailability, Food effect, Tablets formulation, Healthy volunteer
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.
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.
Interventions
DRUGBGB-58067 Tablet (F-01 Formulation)
Administered orally
DRUGBGB-58067 Tablet (F-02 Formulation)
Administered orally
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Approximately 53 Days | Number of participants with adverse events (AEs), abnormal vital signs, electrocardiogram (ECG) findings, clinically significant physical examination abnormalities, and clinically significant laboratory abnormalities. |
Countries
Australia
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed