Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
NCT02207699
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- 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.
- 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.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |