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

Phase 1

Completed

• Conditions: Healthy Volunteers: Asian, Non-Asian
• Interventions: Drug: BGB-3111 (Arm A); Drug: BGB-3111 (Arm B); Drug: Rifampin; Drug: Itraconazole

• Registration Number: NCT03301181
• Lead Sponsor: BeiGene

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.

Study Timeline

• Study Start: 2017-09-18
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-04
• Primary Completion: 2017-11-07
• Study Completion: 2017-11-13
• Status Verified: 2018-06
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	BGB-3111 (Arm A)	Approximately 20 subjects to receive BGB-3111 and rifampin
Arm A	Rifampin	Approximately 20 subjects to receive BGB-3111 and rifampin
Arm B	BGB-3111 (Arm B)	Approximately 20 subjects to receive BGB-3111 and itraconazole
Arm B	Itraconazole	Approximately 20 subjects to receive BGB-3111 and itraconazole

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

West Coast Clinical Trials (WCCT); 🇺🇸 Cypress, California, United States