NCT02215941CompletedPhase 1
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
Teva Branded Pharmaceutical Products R&D, Inc.1 site in 1 country45 target enrollmentStarted: August 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Plasma concentrations
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and/or female subjects aged 18 to 50 years
- •Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m
- •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
- •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
- •Use of topical capsaicin within 6 months prior to Day
- •Pregnant or nursing females
- •Shaving or waxing the planned study treatment application area within 7 days prior Day
- •Laser hair removal of the planned study treatment application area within 2 months prior to Day
- •other criteria apply, please contact the investigator for more information
Arms & Interventions
TV-45070 7%
Experimental
twice daily topical application to 7% body surface area for 7.5 days (15 applications)
Intervention: TV-45070 (Drug)
TV-45070 21%
Experimental
twice daily topical application to 21% body surface area for 7.5 days (15 applications)
Intervention: TV-45070 (Drug)
TV-45070 53%
Experimental
twice daily topical application to 53% body surface area for 7.5 days (15 applications)
Intervention: TV-45070 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Plasma concentrations
Time Frame: Day 8
Secondary Outcomes
- Identification of metabolites in blood(Days 8, 10)
- Intraepidermal nerve fiber density in skin(Days 1, 8, 15, 29)
- Drug level in skin(Days 1, 8, 15, 22, 29)
- Excretion of drug in urine(Day 8)
- Identification of metabolites in urine(Day 8)
- Identification of metabolites in skin(Days 1, 8, 15, 22, 29)
- Percentage of Participants with Adverse Events(10 Weeks)
Investigators
Study Sites (1)
Loading locations...
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