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

• Status: Completed
• Trial end date: 2017-11-13
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: BeiGene
• Treatments: Hydroxyitraconazole; Itraconazole; Rifampin; Zanubrutinib

Criteria

Inclusion Criteria:

1. Body mass index (BMI)18 - 32 kg/m2, inclusive.

2. Subjects of Asian (first- or second-generation) and non-Asian descent.

3. In good general health as assessed by the Investigator.

4. Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.

5. 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:

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

2. Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.

3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.

4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.

5. History of alcoholism or drug/chemical abuse within prior year.