A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects

• Status: Completed
• Trial end date: 2018-07-02
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BeiGene
• Treatments: Zanubrutinib

Criteria

Inclusion Criteria: All Groups

• Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.

• Subjects must have a body mass index (BMI) between 18 and 32 kg/m2.

• Male subjects must agree to a highly effective method of birth control from screening until at least 90 days after the last dose of study drug.

Exclusion Criteria:

• Subjects with a clinically relevant history or presence of any clinically significant disease.

• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).

• History of drug or alcohol abuse within 2 years prior to Check-In.

• Alcohol consumption of >21 units per week.

• A positive urine drug screen and/or positive alcohol breath test at Screening and/or Check-in.

• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening.

• Use of tobacco- or nicotine-containing products within 3 months prior to Check-In.

• History of blood donation of 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.