An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness

Exclusion Criteria

• •1. Regularly uses antihistamines that have been started or the dose adjusted within the last 30 days.
• •2. Has started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before Screening, is not on a stable dosing regimen for at least 14 days prior to the Screening visit, or is unable to maintain stable dosing throughout the study.
• •3. Is unable to withhold the use of systemic cholinergic secretagogues and oral comfort agents (e.g., OraMoist, MouthKote, Biotene products, etc.) on the morning of each study visit and until 2 hours after dosing at study visits; and is unable to take the last nighttime dose at a standard time throughout the study.
• •4. Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.
• •5. Shows evidence of a significant active or ongoing oral infection or other oral conditions (e.g., lichen planus) that, in the opinion of the investigator, might affect the safety of the subject or might exacerbate during study participation.
• •6. Has acutely infected salivary glands (with or without pain) or suspected closure of the salivary glands.
• •7. Has received an investigational drug within the past 30 days.
• •8. Has a history of allergy to any medicine chemically related to the study drug (e.g., amiloride, Moduretic, Midamor, triamterene).
• •9. Has a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular (including hyper/hypotension and tachy/bradycardia), psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the investigator.
• •10. Has viral hepatitis or tested positively for the hepatitis B surface antigen or hepatitis C (nonA, non-B) antibody, or a positive result for human immunodeficiency virus antibodies.
• •11. Has a positive serum pregnancy test or is nursing (female subjects only).
• •12. Should not participate in the study, in the opinion of the Principal or Clinical investigator.