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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05387668
• Other study ID #: BGB-23339-102
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 17, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: December 2022
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BGB-23339
Administered orally as a tablet.
• Placebo
Administered orally as a tablet.

Locations

Country	Name	City	State
United States	PPD	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to end of dosing interval (AUCtau)		Up to Day 10
Secondary	Maximum observed plasma concentration (Cmax) of BGB-23339		Up to Day 10
Secondary	Time to maximum plasma concentration (Tmax) of BGB-23339		Up to Day 10
Secondary	Trough plasma concentration (Ctrough) of BGB-23339		Up to Day 10
Secondary	Apparent terminal elimination half-life (t½) of BGB-23339		Up to Day 10
Secondary	Apparent systemic clearance (CL/F) of BGB-23339		Up to Day 10
Secondary	Apparent volume of distribution (Vz/F) of BGB-23339		Up to Day 10
Secondary	Metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808		Up to Day 10