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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:10/5/2018
Start Date:June 7, 2018
End Date:July 2, 2018

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An Open-label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple Doses of Zanubrutinib With a Drug "Cocktail" Representative for CYP3A4, CYP2C9, CYP2C19, P-gP and BCRP Substrates

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


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.
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Daytona Beach, Florida 32117
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Daytona Beach, FL
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