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A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03432884
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date May 25, 2018
Actual Study Start Date  ICMJE January 25, 2018
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • Part A: Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 8 days ]
    Incidence of treatment-emergent adverse events reported for zanubrutinib compared with placebo
  • Part B: Corrected QT interval [QTc] [ Time Frame: Up to 2 days ]
    Evaluate the effects of single doses of zanubrutinib on the corrected QT interval [QTc] using the Fridericia correction [QTcF]) compared with placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03432884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • Part A: PK Parameters [ Time Frame: Up to 3 days ]
    Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters
  • Part B: Heart Rate (HR) [ Time Frame: Up to 2 days ]
    Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on heart rate (HR)
  • Part B: PR Intervals [ Time Frame: Up to 2 days ]
    Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on PR
  • Part B: QRS Intervals [ Time Frame: Up to 2 days ]
    Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on QRS Intervals
  • Part B: PK Parameters [ Time Frame: Up to 2 days ]
    Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters
  • Part B: Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 16 days ]
    Incidence of treatment-emergent adverse events reported for zanubrutinib
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 A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
Official Title  ICMJE A Two-Part Study Consisting of a Randomized, Placebo-Controlled, Single Dose Safety and Tolerability Study (Part A) Evaluating a Supratherapeutic Dose of Zanubrutinib Followed by a Randomized, Placebo- and Positive-Controlled, Crossover Study (Part B) to Evaluate the Effect of Zanubrutinib on Cardiac Repolarization in Healthy Volunteers
Brief Summary A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
Detailed Description

This is a Two-Part Phase 1 Study.

Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib in eight (8) subjects.

Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover study being conducted in about 28 subjects to investigate the effect of a single therapeutic dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic will be used as a positive control.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Part A: Single Group Part B: Crossover
Masking: Double (Participant, Investigator)
Masking Description:
Part A: zanubrutinib and placebo will be double-blind Part B: zanubrutinib and placebo will be double-blind; Moxifloxacin will be open-label
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: BGB-3111
    Subjects will receive BGB-3111
  • Drug: Placebo
    Subjects will receive Placebo
  • Drug: Moxifloxacin
    Subjects will receive Moxifloxicin
    Other Name: Avelox
Study Arms  ICMJE
  • Experimental: Part A: BGB-3111
    Intervention: Drug: BGB-3111
  • Placebo Comparator: Part A: Placebo
    Intervention: Drug: Placebo
  • Experimental: Part B: BGB-3111, Placebo, and Moxifloxicin
    Interventions:
    • Drug: BGB-3111
    • Drug: Placebo
    • Drug: Moxifloxacin
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: May 24, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2018)
36
Actual Study Completion Date  ICMJE April 16, 2018
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: All subjects

  1. Body mass index (BMI) 18 - 33 kg/m2, inclusive.
  2. In good general health as assessed by the Investigator.
  3. Females of non-child bearing potential.
  4. 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.
  5. Able to comprehend and willing to sign consent.

Exclusion Criteria: All subjects

  1. Subjects with a clinically relevant history or presence of any clinically significant disease.
  2. Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease.
  3. Women of child-bearing potential.
  4. History of alcoholism or drug/chemical abuse within 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT03432884
Other Study ID Numbers  ICMJE BGB-3111-106
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
Plan to Share IPD: Undecided
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BeiGene
Verification Date May 2018

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