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Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02207699
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 16, 2014
First Posted Date  ICMJE August 4, 2014
Last Update Posted Date August 4, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
Fridericia-corrected QTc change from the pre-dose time point to the post-dose time points following administration of study drug in therapeutic (200 mg) and supratherapeutic doses (800 mg). [ Time Frame: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • QT interval for Benzonatate, 4-(butylamino)benzoic acid (BBA-major metabolite of benzonatate), and moxifloxacin. [ Time Frame: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours ]
  • PR interval, QRS complex from single 12-lead electrocardiogram (ECG) [ Time Frame: Screening, Day 0, and Day 1 at 4, 8, and 24 hours after dosing ]
  • Cmax (maximum plasma concentration) for BT and BBA measured in mcg/mL [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • Tmax (time of maximum plasma concentration) for BT and BBA measured in minutes [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • t½ (terminal half-life) for BT and BBA measured in minutes [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • AUClast for BT and BBA measured in mcg•hr/mL [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • AUCinf for BT and BBA measured in mcg•hr/mL [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • Cmax(dn) for BT and BBA measured in mcg/mL [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • AUClast(dn) for BT and BBA measured in mcg•hr/mL [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • AUCinf(dn) for BT and BBA measured in mcg•hr/mL [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • CL/F for BT measured in L/hr [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
  • Vz/F for BT measured in L [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours ]
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 Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
Official Title  ICMJE Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
Brief Summary The primary objective of this study is to determine the effects of benzonatate (200 mg and 800 mg) on the QT interval following single dose oral administration at each time point post-dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Benzonatate 200 mg
    2 benzonatate 100 mg perles and 6 placebo perles give by mouth once
  • Drug: Benzonatate 800 mg
    8 benzonatate 100 mg perles given by mouth once
  • Drug: Moxifloxacin 400 mg
    1 moxifloxacin 400 mg tablet given by mouth once
  • Drug: Placebo
    8 placebo perles given by mouth once
Study Arms  ICMJE
  • Experimental: Benzonatate 200 mg
    Intervention: Drug: Benzonatate 200 mg
  • Experimental: Benzonatate 800 mg
    Intervention: Drug: Benzonatate 800 mg
  • Active Comparator: Moxifloxacin 400 mg
    Intervention: Drug: Moxifloxacin 400 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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: July 31, 2014)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12- lead ECG and clinical laboratory tests.
  • Female subjects of non-childbearing potential must meet at least one of the following criteria:

    1. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum FSH level within the laboratory's reference range for postmenopausal females;
    2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all aspects of the study.
  • Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Significant ECG abnormality at screening as determined by the investigator.
  • History or risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
  • 12-lead ECG demonstrating QTcF >450 msec or a QRS interval >110 msec at Screening.
  • Use of medications or dietary supplements capable of inducing or inhibiting hepatic enzyme metabolism or transport (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone, or St. John's Wort) within 28 days of the first dose of study medication.
  • Consumption of grapefruit or grapefruit containing products within 7 days prior to the first dose of study medication.
  • Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to quinolone antibiotics.
  • Known hypersensitivity to benzonatate or other ester-type local anesthetics (ie, tetracaine, procaine).
  • Subjects with a presence or history of dysphagia or difficulty swallowing pills.
  • Subjects taking any concomitant anticonvulsant medications or with a history of seizure disorder.
  • Subjects with a positive response to the question of actual attempt in the suicidal behavior section of the C-SSRS (Columbia-Suicide Severity Rating Scale). Subjects with active suicidal ideation with intent to act within 6 months of screening as determined by a positive response to questions 4 or 5 in the suicidal ideation section of the C-SSRS.
  • Screening laboratory values considered clinically significant by the investigator.
  • Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest.
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 NCT02207699
Other Study ID Numbers  ICMJE B3551003
BT-10-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2014

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