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Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects

NCT ID: NCT05387668

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2022-10-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part A: Japanese cohort

Three ascending dose levels of either BGB-23339 or placebo.

Group Type EXPERIMENTAL

BGB-23339

Intervention Type DRUG

Administered orally as a tablet.

Placebo

Intervention Type DRUG

Administered orally as a tablet.

Part B: Caucasian cohort

One dose level of either BGB-23339 or placebo based on data collected in Part A.

Group Type EXPERIMENTAL

BGB-23339

Intervention Type DRUG

Administered orally as a tablet.

Placebo

Intervention Type DRUG

Administered orally as a tablet.

Interventions

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BGB-23339

Administered orally as a tablet.

Intervention Type DRUG

Placebo

Administered orally as a tablet.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent form (ICF) and able to comply with study requirements
2. 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:

1. For Part A only: Eligible Japanese subjects should have both biological parents and 4 biological grandparents of Japanese descent, and their 4 biological grandparents must be born in Japan.
2. For Part B only: Eligible Caucasian subjects should 1) have both biological parents and 4 biological grandparents of Caucasian descent, and 2) be matched by body weight (± 20% body weight \[kg\]), height (± 15% height \[centimeter (cm)\]) and sex to each Japanese subject receiving the highest dose level planned in Part A.
3. 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

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. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
3. 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
4. Positive HBV, HCV and HIV test
5. History or risk for tuberculosis (TB)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PPD

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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BGB-23339-102

Identifier Type: -

Identifier Source: org_study_id