Phase 2
Completed N=12
Dose-Escalation Safety and Pharmacokinetic Study of K305
Source: ClinicalTrials.gov NCT01304316 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Cmax of Oxymetazoline — 1.45; 2.05 ng/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Oxymetazoline |
1.45; 2.05 | — |
| PRIMARY Cmax of Tetracaine |
0.243; 1.15 | — |
| PRIMARY Cmax of PBBA |
492; 886 | — |
| PRIMARY Half Life of Oxymetazoline |
2.32; 1.72 | — |
| PRIMARY Half Life of Tetracaine |
— | — |
| PRIMARY Half Life of PBBA |
1.00; 1.01 | — |
| SECONDARY Pulse Oximetry Maximum Change From Baseline |
0.9; 0.3 | — |
| SECONDARY Diastolic BP Maximum Change From Baseline |
10.8; 11.7 | — |
| SECONDARY Systolic BP Maximum Change From Baseline |
10.7; 14.7 | — |
| SECONDARY Pulse Rate Maximum Change From Baseline |
5.2; 8.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01304316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.