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

NCT02207699

Last updated date
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Contact
1-800-718-1021

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]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Healthy VolunteersEvaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers NCT02207699
  1. Overland Park, Kansas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy VolunteersEstimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone NCT01099748
  1. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy VolunteersStudy Of Celecoxib In Healthy Subjects NCT00994461
  1. Yokohama, Kanagawa
  2. Minato-ku, Tokyo
  3. Shinjuku-ku, Tokyo
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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