Benzonatate Dose Tolerance Study

Phase 1

Completed

• Conditions: Cough
• Interventions: Drug: Placebo; Drug: Benzonatate - 400 mg; Drug: Benzonatate - 600 mg

• Registration Number: NCT01690975
• Lead Sponsor: Pfizer

Brief Summary

This is a single-center, randomized, third party blind, placebo controlled, dose escalation study of benzonatate following single dose administration. The primary oobjective is to assess the safety and tolerability of increasing oral doses of benzonatate following single dose administration in healthy male and female subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Study First Posted: 2012-09-24
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Healthy male and/or 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, or clinical laboratory tests.

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Control
Benzonatate	Benzonatate - 400 mg	Benzonatate Active
Benzonatate	Benzonatate - 600 mg	Benzonatate Active

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD): Assessed at end of study	End of study (2 months)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States