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

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

Tracking Information
First Submitted Date  ICMJE September 29, 2017
First Posted Date  ICMJE October 4, 2017
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE September 18, 2017
Actual Primary Completion Date November 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers: Asian, Non-Asian
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 13, 2017
Actual Primary Completion Date November 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03301181
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Novotny, MD BeiGene
PRS Account BeiGene
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP