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Benzonatate

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 4, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02207699Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy VolunteersPHASE1 COMPLETED 68 — — May 1, 2014Jul 1, 2014Aug 4, 20141 United States
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Study Endpoints
Primary Endpoints
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).
-1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours
Secondary Endpoints
QT interval for Benzonatate, 4-(butylamino)benzoic acid (BBA-major metabolite of benzonatate), and moxifloxacin.
-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)
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
0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Benzonatate 200 mgEXPERIMENTAL -
Benzonatate 800 mgEXPERIMENTAL -
Moxifloxacin 400 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Benzonatate 200 mgDRUG2 benzonatate 100 mg perles and 6 placebo perles give by mouth once
Benzonatate 800 mgDRUG8 benzonatate 100 mg perles given by mouth once
Moxifloxacin 400 mgDRUG1 moxifloxacin 400 mg tablet given by mouth once
PlaceboDRUG8 placebo perles given by mouth once
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 an...

Countries:United States
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