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

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.

Inclusion criteria

• Body mass index (BMI)18 - 32 kg/m2, inclusive.
• Subjects of Asian (first- or second-generation) and non-Asian descent.
• In good general health as assessed by the Investigator.
• Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
• Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥90 days after the last dose of BGB-3111.Able to comprehend and willing to sign consent.

Exclusion criteria

• Subjects with a clinically relevant history or presence of any clinically significant disease.
• Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
• History of alcoholism or drug/chemical abuse within prior year.