Dose-Escalation Safety and Pharmacokinetic Study of K305

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Renatus, LLC
• Collaborators: Ground Zero Pharmaceuticals; Rho, Inc.
• Treatments: Oxymetazoline; Phenylephrine; Tetracaine

Criteria

Inclusion Criteria:

• Male or female between 18 and 65 years of age

• BMI between19 and 29 kg/m2

• Sufficiently healthy as determined by the investigator to receive the test medications and undergo the scheduled study procedure

• Can breathe through both nostrils

• Females of child-bearing potential must have a negative urine pregnancy test and must have been using adequate means of birth control for at least one month prior to study entry and during the study

• Screening BP ≤ 140/90

• Screening SpO2 ≥ 96

• Can understand and sign the informed consent document

• Can communicate with the investigator

• Can understand and comply with the requirements of the protocol.

Exclusion Criteria:

• A clinically relevant history or presence of respiratory, thyroid, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, neurologic, musculoskeletal, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of narrow angle glaucoma and in men benign prostatic hypertrophy, Hashimoto"s Thyroiditis, lymphocytic thyroiditis, or uncontrolled diabetes

• Clinically significant abnormalities in laboratory values

• Clinically relevant sinus/nasal surgical history

• Current condition, such as nasal congestion or sinus infection, that may influence responses to study medication

• History of recurrent nose bleeds

• History of pseudocholinesterase deficiency or previous prolonged paralysis with succinylcholine or "difficulty waking up from general anesthesia"

• Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens)

• Allergic to or intolerant of oxymetazoline or preservatives found in these solutions

• History of alcoholism and/or drug abuse

• Have taken a monamine oxidase inhibitor, or vasopressor drug within the past 3 weeks

• Have received or taken local anesthetics within 72 hours of the first or second treatment visits

• Are nursing, pregnant, suspected of being pregnant, or trying to become pregnant (Females will be required to take a urine pregnancy test at each study visit to rule out pregnancy)

• Have used any investigational drug and/or participated in any clinical trial within 30 days of baseline