Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

Study Overview
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Brief Summary
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The purpose of this research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration.

Official Title
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An Exploratory, Randomized, Placebo Controlled, Double Blind, Parallel Arm Dose Ranging Study to Determine the Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

Conditions
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Acute Cough

Intervention / Treatment
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* Drug: FP01


Participation Criteria
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Eligibility Criteria
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gastroesophageal INCLUSION CRITERIA Subject must state that they have had a cold for < 14 days. A cold is defined as: Moderate or severe rhinorrhea (i.e., using 2 or more tissues per hour for any 1 hour within 12 hours preceding study screening AND At least one other respiratory symptom (cough, pharyngeal symptoms [sore throat], nasal congestion of moderate or severe intensity, headache, etc.) Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS score ≥ 40 mm). Subjects who recall that their average number of days with cough during their usual cold history is 3 or greater (URTI cough history > 3). Subjects who do not smoke or use nicotine or nicotine containing products. Ex-smokers/ex-tobacco users must have stopped using tobacco products for at least 6 months prior to study screening. Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) with a negative serum beta human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and who are using or agree to use an acceptable method of contraception as determined by the Investigator. Acceptable contraceptives include abstinence OR intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) for ≥ three months prior to screening OR use of double barrier methods such as condoms or diaphragms with spermicidal gel or foam. Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits. EXCLUSION CRITERIA Subject who are using antibiotics at study screening or for whom antibiotics are currently indicated as determined by the Investigator. History of cough of greater than 6 weeks in duration. History of any chronic pulmonary disease including tuberculosis, lung cancer, chronic bronchitis or emphysema History of pneumonia, influenza or whooping cough within the past 30 days. History of asthma that required any treatment within 2 weeks of study T > 38.5oC with no history of anti-pyretic medication for > 24 hours from screening visit History of inhalational exposure (chemical, smoke, water, etc.) within the past 6 months Chest X-ray suggestive of granulomatous disease, malignancy, COPD, bronchiectasis, pneumonia, pleural processes or other underlying pulmonary disease Active, concurrent concomitant disease which might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., diabetes mellitus, congestive heart failure, unstable angina, etc.) Prior or current renal disease; calculated creatinine clearance < 30 ml/min (calculated ClCr < 30) Known immune deficiency condition Use of opioids or anticonvulsants within 3 days of study screening. Known hypersensitivity to memantine or lozenge excipients. Current oral lesions or abnormal findings on buccal examination done at study screening. History of oropharyngeal or gastroesophageal carcinoma, or gastro/esophageal/duodenal resection. Subject has clinically significant abnormal laboratory test results at the screening visit. (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor.) Any clinically significant finding on the ECG done at the screening visit, as determined by the investigator. (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor). Female subjects who are pregnant, breast feeding or sexually active without contraception. Subject has donated blood or plasma within the last 45 days. Subject has history of alcohol or drug abuse in past 2 years. Subject has a positive drug screen. Subject has a positive HIV, Hepatitis B or Hepatitis C test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FP01 High dose<br> | Drug: FP01<br>* Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.<br>|
| Experimental: FP01 Low dose<br> | Drug: FP01<br>* Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.<br>|
| Placebo Comparator: Placebo<br> | Drug: FP01<br>* Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cough count, active vs placebo treatment period |  | Daily for 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The evaluation of treatment safety will take into account the recorded adverse events, vital signs, clinical and laboratory assessments and the buccal cavity examination | Daily over 3 days |