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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

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BGB-3111 Drug: Placebo Drug: Moxifloxacin Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: 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
Actual Study Start Date : January 25, 2018
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: BGB-3111 Drug: BGB-3111
Subjects will receive BGB-3111

Placebo Comparator: Part A: Placebo Drug: Placebo
Subjects will receive Placebo

Experimental: Part B: BGB-3111, Placebo, and Moxifloxicin Drug: BGB-3111
Subjects will receive BGB-3111

Drug: Placebo
Subjects will receive Placebo

Drug: Moxifloxacin
Subjects will receive Moxifloxicin
Other Name: Avelox




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Part A: PK Parameters [ Time Frame: Up to 3 days ]
    Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters

  2. 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)

  3. 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

  4. 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

  5. Part B: PK Parameters [ Time Frame: Up to 2 days ]
    Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432884


Locations
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United States, New Jersey
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07094
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03432884     History of Changes
Other Study ID Numbers: BGB-3111-106
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by BeiGene:
Phase 1
pharmacokinetics
safety

Additional relevant MeSH terms:
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Moxifloxacin
Zanubrutinib
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors