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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Administered orally
Administered orally
Cmax Clinical Research
Adelaide, South Australia, Australia
RECRUITINGArea 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
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.
Time frame: Approximately 53 Days
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