Benzonatate Dose Tolerance Study

A Phase I, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Tolerability of Benzonatate Following Single Dose Administration in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: Placebo; Drug: Benzonatate - 400 mg; Drug: Benzonatate - 600 mg

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Control	Drug: Placebo; Placebo - single dose at start of each treatment period
Experimental: Benzonatate; Benzonatate Active	Drug: Benzonatate - 400 mg; Benzonatate - 400 mg single dose; Drug: Benzonatate - 600 mg; Benzonatate - 600 mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Maximum tolerated dose (MTD): Assessed at end of study	End of study (2 months)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 19, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory System Agents; Antitussive Agents; Benzonatate
• Other Study ID Numbers: B3551001; BT-10-29