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

Healthy Volunteers: Asian, Non-Asian Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301181
• Other study ID #: BGB-3111-104
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: June 2018
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 13, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers: Asian, Non-Asian

Intervention

Drug:
• BGB-3111 (Arm A)
320 mg BGB-3111 single oral dose
• Rifampin
600 mg rifampin once daily
• BGB-3111 (Arm B)
Up to 80 mg BGB-3111 single oral dose
• Itraconazole
200 mg itraconazole once daily

Locations

Country	Name	City	State
United States	West Coast Clinical Trials (WCCT)	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters		Part A: Days 1 and 10
Primary	Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters		Part B: Days 1 and 6
Secondary	Safety as assessed by adverse events		Part A: up to 19 days: Part B: up to 14 days
Secondary	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