Pharmacokinetic Study of Synera in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Synera

• Registration Number: NCT01602757
• Lead Sponsor: ZARS Pharma Inc.

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Synera	Synera	Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat ("no heat patches") and were crossed over during Study Session 3.

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of Synera after application of 4 patches	0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose	Peak plasma concentration of Synera after application of 4 patches for 2-, 4- and 12-hours

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time (AUC) of Synera	0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose	Area under the plasma concentration versus time curve of Synera after application of 4 patches for 2-, 4-, and 12 hours
Number of participants with adverse events	24 days

Trial Locations

Locations (1)

Cetero Research; 🇺🇸 Fargo, North Dakota, United States