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

NCT05387668 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: BGB-23339-102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Part A: Japanese cohort

EXPERIMENTAL

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

Drug: BGB-23339; Drug: Placebo

Part B: Caucasian cohort

EXPERIMENTAL

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

Drug: BGB-23339; Drug: Placebo

Interventions

BGB-23339 DRUG

Administered orally as a tablet.

Part A: Japanese cohort; Part B: Caucasian cohort

Placebo DRUG

Administered orally as a tablet.

Part A: Japanese cohort; Part B: Caucasian cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• 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.
• 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

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• Medical Conditions
• 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
• 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
• Positive HBV, HCV and HIV test
• History or risk for tuberculosis (TB)

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

PPD

Las Vegas, Nevada, 89113, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: February 17, 2022
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

US (1)