Not Determined
Conditions
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
Interventions
DRUGBGB-23339
Administered orally as a tablet
DRUGPlacebo
Administered orally as a tablet
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent form (ICF) and able to comply with study requirements 2. Healthy men and/or women of no childbearing potential of age ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent) for Parts A, B and D; of age≥ 18 years and ≤ 45 years on the day of signing the ICF (or the legal age of consent) and of Chinese descent for Part C 3. Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring 4. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive) 5. A nonsterile man with a female partner of childbearing potential must be willing to use a highly effective method of birth control from the time of study enrollment until 90 days after the last dose of study drug 6. A woman of no childbearing potential must meet at least one of the following criteria: 1. Postmenopausal status, defined as: cessation of regular menses for ≥ 12 consecutive months (menopause confirmed by Follicular Stimulating Hormone \[FSH\] levels and Luteinizing Hormone \[LH\] levels as defined by the established reference ranges) 2. Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).
Exclusion criteria
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data 2. Abnormal blood pressure as determined by the investigator 3. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization) 4. Any malignancies within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years 5. Past or intended use of prescription medication ≤ 14 days and over-the-counter (OTC) medication including herbal, vitamins and dietary supplements ≤ 7 days before randomization 6. Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization 7. Has received an investigational product within the following time before randomization: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer) 8. Participation in a prior study that would result in loss of blood or blood products in excess of 500 mL within 56 days before randomization 9. Exposure to ≥ 4 new chemical entities within 12 months before randomization 10. Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization 11. Regular alcohol consumption ≤ 3 months before randomization 12. Regular use of recreational drugs 13. Current use and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 14 days before randomization Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Up to approximately 7 weeks | — |
| Number of participants with clinically significant changes from baseline in vital signs | Up to approximately 4 weeks | Vital signs include blood pressure and pulse rate |
| Number of participants with clinically significant changes from baseline in clinical laboratory values | Up to approximately 4 weeks | Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D | Up to approximately 4 weeks | — |
| Maximum observed plasma concentration (Cmax) for Parts A, B, C and D | Up to approximately 4 weeks | — |
| Time to maximum plasma concentration (Tmax) for Parts A, B, C and D | Up to approximately 4 weeks | — |
| Trough plasma concentration (Ctrough) for Parts A, B, and C | Up to approximately 4 weeks | — |
| Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D | Up to approximately 4 weeks | — |
| Apparent systemic clearance (CL/F) for Parts A, B, and C | Up to approximately 4 weeks | — |
| Apparent volume of distribution (Vz/F) for Parts A, B, and C | Up to approximately 4 weeks | — |
| Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D | Up to approximately 4 weeks | — |
| Apparent terminal elimination half-life (t½) for Parts A, B, C and D | Up to approximately 4 weeks | in fed and fasted states for BGB-23339 |
| Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only | Up to approximately 4 weeks | — |
| Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D | Up to approximately 4 weeks | — |
Countries
Australia, China
Outcome results
None listed