Dose-Escalation Safety and Pharmacokinetic Study of K305

NCT01304316 | Completed Phase 2 Results

• 1 other identifier: SR 2-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (6)

• Cmax of Oxymetazoline

  Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Cmax of Tetracaine

  Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Cmax of PBBA

  Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Half Life of Oxymetazoline

  Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Half Life of Tetracaine

  Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Half Life of PBBA

  Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

Secondary Outcomes (4)

• Pulse Oximetry Maximum Change From Baseline

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Diastolic BP Maximum Change From Baseline

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Systolic BP Maximum Change From Baseline

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

• Pulse Rate Maximum Change From Baseline

  Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

Study Arms (1)

Kovacaine Nasal Spray

EXPERIMENTAL

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% DRUG

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Also known as: Kovacaine Nasal Spray

Kovacaine Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• St. Renatus, LLC: lead
• Ground Zero Pharmaceuticals: collaborator
• Rho, Inc.: collaborator

Study Sites (1)

University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Tetracaine

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Elliot V. Hersh
• Organization: University of Pennsylvania

evhersh@pobox.upenn.edu

215-898-9686

Study Officials

• Elliot V Hersh, DMD, MS, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 25, 2011
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-07

Locations

US (1)