NCT05387668

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BGB-23339	Administered orally as a tablet.
DRUG	Placebo	Administered orally as a tablet.

Timeline

• Start date: 2022-02-17
• Primary completion: 2022-10-17
• Completion: 2022-10-17
• First posted: 2022-05-24
• Last updated: 2022-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study