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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BGB-23339; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Each subject must meet all of the following inclusion criteria to be considered eligible for participation in this study:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Japanese cohort; Three ascending dose levels of either BGB-23339 or placebo.	Drug: BGB-23339; Administered orally as a tablet.; Drug: Placebo; Administered orally as a tablet.
Experimental: Part B: Caucasian cohort; One dose level of either BGB-23339 or placebo based on data collected in Part A.	Drug: BGB-23339; Administered orally as a tablet.; Drug: Placebo; Administered orally as a tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Anticipated): October 17, 2022
• Study Completion (Anticipated): October 17, 2022

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BGB-23339-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No