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

• ClinicalTrials.gov Identifier: NCT03301181
• Recruitment Status: Completed
• First Posted: October 4, 2017
• Last Update Posted: November 1, 2019
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: September 29, 2017
• First Posted Date: October 4, 2017
• Last Update Posted Date: November 1, 2019
• Actual Study Start Date: September 18, 2017
• Actual Primary Completion Date: November 7, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2017)

• Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters [ Time Frame: Part A: Days 1 and 10 ]
• Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters [ Time Frame: Part B: Days 1 and 6 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 3, 2017)

• Safety as assessed by adverse events [ Time Frame: Part A: up to 19 days: Part B: up to 14 days ]
• Safety as assessed by electrocardiogram (ECG) measurements [ Time Frame: 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy Volunteers: Asian, Non-Asian

Intervention

• Drug: BGB-3111 (Arm A)
  320 mg BGB-3111 single oral dose
• Drug: Rifampin
  600 mg rifampin once daily
  Other Name: Rifadin, Rimactane
• Drug: BGB-3111 (Arm B)
  Up to 80 mg BGB-3111 single oral dose
• Drug: Itraconazole
  200 mg itraconazole once daily
  Other Name: Sporanox, Orungal

Study Arms

• Experimental: Arm A
  Approximately 20 subjects to receive BGB-3111 and rifampin
  Interventions:

  • Drug: BGB-3111 (Arm A)
  • Drug: Rifampin
• Experimental: Arm B
  Approximately 20 subjects to receive BGB-3111 and itraconazole
  Interventions:

  • Drug: BGB-3111 (Arm B)
  • Drug: Itraconazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2017): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 13, 2017
• Actual Primary Completion Date: November 7, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03301181
• Other Study ID Numbers: BGB-3111-104
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: BeiGene
• Original Responsible Party: Same as current
• Current Study Sponsor: BeiGene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: William Novotny, MD; BeiGene

• PRS Account: BeiGene
• Verification Date: June 2018