NCT03301181

Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects

A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (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 rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111

Detailed description

This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.

Conditions

• Healthy Volunteers: Asian, Non-Asian

Interventions

Type	Name	Description
DRUG	BGB-3111 (Arm A)	320 mg BGB-3111 single oral dose
DRUG	Rifampin	600 mg rifampin once daily
DRUG	BGB-3111 (Arm B)	Up to 80 mg BGB-3111 single oral dose
DRUG	Itraconazole	200 mg itraconazole once daily

Timeline

• Start date: 2017-09-18
• Primary completion: 2017-11-07
• Completion: 2017-11-13
• First posted: 2017-10-04
• Last updated: 2019-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study