Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection)

NCT01807624 | Completed Phase 2 Results

• 1 other identifier: SR 2-06
• Study Type: interventional
• Target: 24
• 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 with blood draws over 24 hours.

Conditions

Anesthesia

Keywords

Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• Cmax of Oxymetazoline and PBBA

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• Tmax of Oxymetazoline and PBBA

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• Half-life of Oxymetazoline and PBBA

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• AUC0-t of Oxymetazoline and PBBA

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• AUC0-infinity of Oxymetazoline and PBBA

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Secondary Outcomes (8)

• Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

• Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication

  0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Study Arms (1)

Kovacaine Mist

EXPERIMENTAL

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% DRUG

1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)

Also known as: Kovacaine Nasal Spray

Kovacaine Mist

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-breast-feeding female subjects between the ages of 18 and 75 years (inclusive).
• Can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.
• Body mass index between 18 and 35 BMI.
• Sufficiently healthy as determined by the investigator to receive the test medications and undergo the scheduled study procedure.
• Can breathe through both nostrils.
• Screening BP ≤ 140/90 mm Hg.

You may not qualify if:

• History of clinically significant respiratory, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, including cardiac arrhythmia, narrow angle glaucoma and benign prostatic hypertrophy (in men), uncontrolled thyroid disease (including Hashimoto's Thyroiditis and lymphocytic thyroiditis), uncontrolled diabetes mellitus or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Has clinically significant abnormal findings on the physical examination, medical history, electrocardiogram (ECG), or clinical laboratory evaluation during screening. This includes current upper respiratory infections.
• Currently experiencing seasonal or perennial allergic rhinitis, recurrent nose-bleeds or asthma, or has a significant history of these conditions, in the opinion of the Investigator.
• Current, including the last 30 days, sinusitis or other upper respiratory infections.
• Nasal polyps, significant nasal or sinus surgery or other abnormality that may interfere with the dose administration.
• History of allergic or adverse responses to tetracaine, other ester local anesthetics, PBBA, oxymetazoline and its preservatives, or para-aminobenzoic acid as found in PABA containing sunscreens or any comparable or similar product.
• Donation of blood or plasma within 30 days of the first dose of Study Drug.
• Participation in a clinical trial within 30 days prior to the first dose of Study Drug.
• Use of any new over-the-counter (OTC) medication, including topical anesthetic creams or gels, vitamins, within seven days prior to the first dose of the Study Drug or during the study unless approved by the Principal Investigator.
• Any prescription medication, whose dose is not stable at the time of screening, as determined by the Principal Investigator.
• Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of Study Drug or during the study.
• Smoking or use of tobacco products within 6 months prior to the first dose of Study Drug or during the study.
• Female trying to conceive, is pregnant, suspected of being pregnant, or is lactating. (Females of child-bearing potential will be required to take a serum pregnancy test at screening (up to 21 days prior to the start of the study, including the day of the study), as well as a urine pregnancy test at check-in to rule out pregnancy.)
• Positive serum pregnancy test at screening or urine pregnancy test at check-in for all women of childbearing potential.
• Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol, drugs of abuse, or cotinine.

Sponsors & Collaborators

• St. Renatus, LLC: lead
• Triligent International: collaborator
• Rho, Inc.: collaborator
• Analytical Bio-Chemistry Laboratories, Inc.: collaborator

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, 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. Derek Muse
• Organization: Jean Brown Research Center

participate@jeanbrownresearch.com

(801) 261-2000

Study Officials

• Jim Mulvahill

  St. Renatus

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 8, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 30, 2017
• Results First Posted: December 29, 2016

Record last verified: 2017-07

Locations

US (1)