Status:
COMPLETED
Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Lead Sponsor:
BeiGene
Conditions:
Healthy Volunteers: Asian, Non-Asian
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 CY...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03301181
Start Date
September 18 2017
End Date
November 13 2017
Last Update
November 1 2019
Active Locations (1)
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1
West Coast Clinical Trials (WCCT)
Cypress, California, United States, 90630