Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers

Study Overview
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Brief Summary
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The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.

Official Title
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A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study to Characterize the Pharmacokinetics and Safety of 8% TV-45070 Ointment Following 7.5 Days of Twice Daily Topical Application in Healthy Subjects

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: TV-45070
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects aged 18 to 50 years Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2. Able and willing to provide written informed consent. Able and willing to comply with all study procedures and restrictions. Exclusion Criteria: History or evidence of clinically significant illness or surgery Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the proposed application area that would interfere with the application of the study drug treatments or biopsies. History of significant drug or alcohol abuse Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1. Use of topical application of an OTC medicated or prescription medication or other skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months prior to Day 1. Pregnant or nursing females Shaving or waxing the planned study treatment application area within 7 days prior Day 1. Laser hair removal of the planned study treatment application area within 2 months prior to Day 1. other criteria apply, please contact the investigator for more information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TV-45070 7%<br>twice daily topical application to 7% body surface area for 7.5 days (15 applications) | Drug: TV-45070<br>* TV-45070 8% ointment<br>|
| Experimental: TV-45070 21%<br>twice daily topical application to 21% body surface area for 7.5 days (15 applications) | Drug: TV-45070<br>* TV-45070 8% ointment<br>|
| Experimental: TV-45070 53%<br>twice daily topical application to 53% body surface area for 7.5 days (15 applications) | Drug: TV-45070<br>* TV-45070 8% ointment<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug level in skin |  | Days 1, 8, 15, 22, 29 | 
| Excretion of drug in urine |  | Day 8 | 
| Identification of metabolites in blood |  | Days 8, 10 | 
| Identification of metabolites in urine |  | Day 8 | 
| Identification of metabolites in skin |  | Days 1, 8, 15, 22, 29 | 
| Intraepidermal nerve fiber density in skin |  | Days 1, 8, 15, 29 | 
| Percentage of Participants with Adverse Events |  | 10 Weeks |