Clinical trial NCT01602757: Pharmacokinetic Study of Synera in Healthy Volunteers
Official title: An Open-Label Pharmacokinetic Study of the Synera Patch Applied for 2-, 4-, and 12-hours and a Lidocaine/Tetracaine Patch Without Heat Applied for 4 Hours in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.

Detailed description: The purpose of this study was to evaluate the pharmacokinetic profiles of lidocaine and tetracaine after 2-, 4-, and 12-hour application of 4 Synera® patches and a 4-hour application of 4 lidocaine/tetracaine patches without heat in healthy adult subjects and to monitor the frequency and nature of adverse events. In addition to determining the pharmacokinetics for a one-time application of 4 Synera® patches, steady-state pharmacokinetics were modeled and residual patch concentrations of lidocaine and tetracaine were determined.

Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* be a nonsmoker
* have a body mass index (BMI) ≥ 18.5 and \< 30.0

Exclusion Criteria:

* known or suspected hypersensitivity, allergies, or other contraindications to any compound present in the study drug, including lidocaine, tetracaine, or other local anesthetics.
* have a defect, injury or a dermatological disease or condition in the skin area where the study drug was to be applied.
* have a history or current evidence of any hepatic impairment.
* have failed the urine drug screen.
* have used or been administered a local or systemic anesthetic, including over-the-counter products, within the past 14 days.
* have donated blood or plasma within the past 30 days.
* have participated in a clinical research study within the past 30 days.
* are pregnant, breastfeeding, or was a female of childbearing potential and not practicing adequate birth control

Primary outcomes:
measure: Peak plasma concentration (Cmax) of Synera after application of 4 patches
timeFrame: 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 24 days
measure: Area under the plasma concentration versus time (AUC) of Synera
timeFrame: 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Cetero Research
state: North Dakota
Study officials:
affiliation: Cetero Research, San Antonio
name: Anthony R Godfrey, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marriott TB, Charney MR, Stanworth S. Effects of application durations and heat on the pharmacokinetic properties of drug delivered by a lidocaine/tetracaine patch: a randomized, open-label, controlled study in healthy volunteers. Clin Ther. 2012 Oct;34(10):2174-83. doi: 10.1016/j.clinthera.2012.08.008. Epub 2012 Sep 1.