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This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Dose Escalation (Single Ascending Dose) | Experimental | Up to 5 dose levels of BGB-23339 or Placebo |
|
| Part B Dose Escalation (Multiple Ascending Dose) | Experimental | Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A |
|
| Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) | Experimental | Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only) |
|
| Part D (Food-Effect Study) | Experimental | Three single dose levels of BGB-23339 under different feeding conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-23339 | Drug | Administered orally as a tablet |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q PHARM | Herston | Queensland | QLD 4006 | Australia | ||
| Nucleus Network |
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| Placebo | Drug | Administered orally as a tablet |
|
| 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 |
| Melbourne |
| Victoria |
| VIC 3004 |
| Australia |
| The Affiliated Hospital of Qingdao University Branch West Coast | Qingdao | Shandong | 266555 | China |