First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants

Official Title
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A First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Subjects

Conditions
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Not Determined

Intervention / Treatment
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* Drug: BGB-23339
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form (ICF) and able to comply with study requirements 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 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 Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive) 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 A woman of no childbearing potential must meet at least one of the following criteria: 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) Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months). Exclusion Criteria: 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 Abnormal blood pressure as determined by the investigator Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization) 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 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 Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization 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) 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 Exposure to ≥ 4 new chemical entities within 12 months before randomization Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization Regular alcohol consumption ≤ 3 months before randomization Regular use of recreational drugs 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/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A Dose Escalation (Single Ascending Dose)<br>Up to 5 dose levels of BGB-23339 or Placebo | Drug: BGB-23339<br>* Administered orally as a tablet<br>Drug: Placebo<br>* Administered orally as a tablet<br>|
| Experimental: Part B Dose Escalation (Multiple Ascending Dose)<br>Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A | Drug: BGB-23339<br>* Administered orally as a tablet<br>Drug: Placebo<br>* Administered orally as a tablet<br>|
| Experimental: Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)<br>Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only) | Drug: BGB-23339<br>* Administered orally as a tablet<br>Drug: Placebo<br>* Administered orally as a tablet<br>|
| Experimental: Part D (Food-Effect Study)<br>Three single dose levels of BGB-23339 under different feeding conditions | Drug: BGB-23339<br>* Administered orally as a tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events (AEs) |  | Up to approximately 7 weeks | 
| Number of participants with clinically significant changes from baseline in vital signs | Vital signs include blood pressure and pulse rate | Up to approximately 4 weeks | 
| Number of participants with clinically significant changes from baseline in clinical laboratory values | Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis | Up to approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Apparent terminal elimination half-life (t½) for Parts A, B, C and D | in fed and fasted states for BGB-23339 | 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 |