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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects

Conditions
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Healthy Volunteers: Asian, Non-Asian

Intervention / Treatment
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* Drug: BGB-3111 (Arm A)
* Drug: Rifampin
* Drug: BGB-3111 (Arm B)
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Approximately 20 subjects to receive BGB-3111 and rifampin | Drug: BGB-3111 (Arm A)<br>* 320 mg BGB-3111 single oral dose<br>Drug: Rifampin<br>* 600 mg rifampin once daily<br>* Other names: Rifadin, Rimactane;|
| Experimental: Arm B<br>Approximately 20 subjects to receive BGB-3111 and itraconazole | Drug: BGB-3111 (Arm B)<br>* Up to 80 mg BGB-3111 single oral dose<br>Drug: Itraconazole<br>* 200 mg itraconazole once daily<br>* Other names: Sporanox, Orungal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters |  | Part A: Days 1 and 10 | 
| Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters |  | Part B: Days 1 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by adverse events |  | Part A: up to 19 days: Part B: up to 14 days | 
| Safety as assessed by electrocardiogram (ECG) measurements |  | Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14 |