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Benzonatate

Phase 1

Cough | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Aug 4, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

Benzonatate · 2 trials · 2 indications

Phase 1 2
NCT02207699Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy VolunteersHealthy Volunteers
COMPLETED68 Analytics
NCT01690975Benzonatate Dose Tolerance StudyCough
COMPLETED9 Analytics
PHASE1COMPLETED
Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Benzonatate Dose Tolerance Study
CoughUnlock trial analytics

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
Maximum Observed Plasma Concentration (Cmax)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Plasma Decay Half-Life (t1/2)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose

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 -
BenzonatateEXPERIMENTALBenzonatate Active

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
Benzonatate - 400 mgDRUGBenzonatate - 400 mg single dose
Benzonatate - 600 mgDRUGBenzonatate - 600 mg single dose
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Benzonatate

What is Benzonatate used for?

Benzonatate is a small molecule being studied for use in cough and in healthy volunteers. It is currently in Phase 1 clinical development. Benzonatate is being developed by Pfizer, Inc. (NYSE: PFE).

What does Benzonatate target?

Benzonatate is a small molecule in development for respiratory conditions, specifically cough. Its molecular target has not been disclosed in available clinical trial information. The drug is being evaluated in Phase 1 studies.

Who makes Benzonatate?

Benzonatate is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for cough and healthy volunteer studies.

What phase is Benzonatate in?

Benzonatate is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both in the United States.

What clinical trials is Benzonatate in?

Benzonatate has been studied in two completed Phase 1 clinical trials. NCT01690975 was a dose tolerance study in cough with 9 participants. NCT02207699 evaluated the effect of Benzonatate on QT intervals in 68 healthy volunteers. Both trials were conducted in the United States.

Is Benzonatate the same as Tessalon?

Benzonatate is not listed under any alternative names in the available clinical trial information. It is being studied under the name Benzonatate in Phase 1 trials for cough and healthy volunteer studies.