Clinical trial NCT03301181: Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers: Asian, Non-Asian
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2017-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility 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.

Primary outcomes:
measure: Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
timeFrame: Part A: Days 1 and 10
measure: Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters
timeFrame: Part B: Days 1 and 6
Secondary outcomes:
measure: Safety as assessed by adverse events
timeFrame: Part A: up to 19 days: Part B: up to 14 days
measure: Safety as assessed by electrocardiogram (ECG) measurements
timeFrame: 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
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials (WCCT)
state: California
Study officials:
affiliation: BeiGene
name: William Novotny, MD
role: STUDY_DIRECTOR
References: