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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03301181

Enrollment

Registered

2017-10-04

Start date

2017-09-18

Completion date

2017-11-13

Last updated

2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers: Asian, Non-Asian

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.

Interventions

DRUGBGB-3111 (Arm A)

320 mg BGB-3111 single oral dose

DRUGRifampin

600 mg rifampin once daily

DRUGBGB-3111 (Arm B)

Up to 80 mg BGB-3111 single oral dose

DRUGItraconazole

200 mg itraconazole once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026