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

Sponsor

BeiGene (Industry)

Overall Status

Completed

CT.gov ID

NCT03301181

Collaborator

(none)

Enrollment

Location

Arms

1.8

Actual Duration (Months)

21.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers: Asian, Non-Asian	Drug: BGB-3111 (Arm A) Drug: Rifampin Drug: BGB-3111 (Arm B) Drug: Itraconazole	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Sep 18, 2017

Actual Primary Completion Date :

Nov 7, 2017

Actual Study Completion Date :

Nov 13, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm A

Approximately 20 subjects to receive BGB-3111 and rifampin

Drug: BGB-3111 (Arm A)

320 mg BGB-3111 single oral dose

Drug: Rifampin

600 mg rifampin once daily

Other Names:

Rifadin, Rimactane

Experimental: Arm B

Approximately 20 subjects to receive BGB-3111 and itraconazole

Drug: BGB-3111 (Arm B)

Up to 80 mg BGB-3111 single oral dose

Drug: Itraconazole

200 mg itraconazole once daily

Other Names:

Sporanox, Orungal

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Clinical Trials (WCCT)	Cypress	California	United States	90630

Sponsors and Collaborators

BeiGene

Investigators

Study Director: William Novotny, MD, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BeiGene

ClinicalTrials.gov Identifier:

NCT03301181

Other Study ID Numbers:

BGB-3111-104

First Posted:

Oct 4, 2017

Last Update Posted:

Nov 1, 2019

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Itraconazole

Rifampin

Zanubrutinib

Study Results

No Results Posted as of Nov 1, 2019