NCT04163523

Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects

A Single Center, Phase I, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of BGB-3111 Given Orally at 320 mg QD in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase 1 study in healthy subjects to determine the effect of food on the pharmacokinetics of BGB-3111.

Detailed description

A randomized, crossover study to evaluate the effect of food on pharmacokinetics of BGB-3111 when administered in subjects either after a high fat/calorie meal or a low fat/calorie meal or after an overnight fast.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Zanubrutinib

Timeline

• Start date: 2016-05-25
• Primary completion: 2016-07-21
• Completion: 2016-07-21
• First posted: 2019-11-14
• Last updated: 2024-12-27

Locations

5 sites across 1 country: Australia