Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor determined the data was no longer needed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.
The study comprises 2 parts: Part A is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Japanese subjects. Part B is a randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Caucasian subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Japanese cohort | Experimental | Three ascending dose levels of either BGB-23339 or placebo. |
|
| Part B: Caucasian cohort | Experimental | One dose level of either BGB-23339 or placebo based on data collected in Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-23339 | Drug | Administered orally as a tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, and electrocardiogram results. | Duration of Study (Up to 11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to last quantifiable time (AUClast) quantifiable time (AUClast) | Up to Day 10 | |
| Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to end of dosing interval (AUCtau) |
Not provided
Inclusion Criteria:
Each subject must meet all of the following inclusion criteria to be considered eligible for participation in this study:
Signed informed consent form (ICF) and able to comply with study requirements
Healthy Japanese or Caucasian men and/or women of no childbearing potential aged ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent), and to be specific:
Subjects 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
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Medical Conditions
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Las Vegas | Nevada | 89113 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered orally as a tablet. |
|
| Up to Day 10 |
| Maximum observed plasma concentration (Cmax) of BGB-23339 | Up to Day 10 |
| Time to maximum plasma concentration (Tmax) of BGB-23339 | Up to Day 10 |
| Trough plasma concentration (Ctrough) of BGB-23339 | Up to Day 10 |
| Apparent terminal elimination half-life (t½) of BGB-23339 | Up to Day 10 |
| Apparent systemic clearance (CL/F) of BGB-23339 | Up to Day 10 |
| Apparent volume of distribution (Vz/F) of BGB-23339 | Up to Day 10 |
| Metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 | Up to Day 10 |