Dose-Escalation Safety and Pharmacokinetic Study of K305

Completed · Phase 2

Conditions studied: Anesthesia

In brief

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

Key facts

Study ID

NCT01304316

Run by

St. Renatus, LLC

People needed

12

Starts

2010-09-01

Expected to finish

2010-11-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania, School of Dental Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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