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

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66212 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02207699
Pfizer
Completed
Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers

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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 SummaryThe 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 DescriptionNot 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 DateJuly 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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