Phase 1, Randomized, Comparative Pharmacokinetic Study of Bolus Intravenous Lidocaine 0.7 mg/kg, Lidocaine Patch 1.8%, and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Lidocaine patch 1.8%
- Conditions
- Healthy
- Sponsor
- Scilex Pharmaceuticals, Inc.
- Enrollment
- 58
- Primary Endpoint
- Peak plasma concentration (Cmax) of lidocaine
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be healthy based on by medical history, laboratory work, and physical exam
- •Be at least 18 years of age to 65 years of age
- •If childbearing potential, use of acceptable form of birth control
- •In the case of females of childbearing potential, have a negative serum pregnancy test
Exclusion Criteria
- •Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication
- •Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation
- •Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
Arms & Interventions
Lidocaine Patch (Sequence AB)
Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.
Intervention: Lidocaine patch 1.8%
Lidocaine Patch (Sequence AB)
Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.
Intervention: Lidocaine 5% patch
Lidocaine Patch (Sequence AB)
Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.
Intervention: Lidocaine 2% Injectable Solution
Lidocaine Patch (Sequence BA)
Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.
Intervention: Lidocaine patch 1.8%
Lidocaine Patch (Sequence BA)
Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.
Intervention: Lidocaine 5% patch
Lidocaine Patch (Sequence BA)
Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.
Intervention: Lidocaine 2% Injectable Solution
Outcomes
Primary Outcomes
Peak plasma concentration (Cmax) of lidocaine
Time Frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours
Time Frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity
Time Frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma