Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers
NCT ID: NCT02215941
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2014-08-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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TV-45070 7%
twice daily topical application to 7% body surface area for 7.5 days (15 applications)
TV-45070
TV-45070 8% ointment
TV-45070 21%
twice daily topical application to 21% body surface area for 7.5 days (15 applications)
TV-45070
TV-45070 8% ointment
TV-45070 53%
twice daily topical application to 53% body surface area for 7.5 days (15 applications)
TV-45070
TV-45070 8% ointment
Placebo
Placebo
Placebo
Interventions
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TV-45070
TV-45070 8% ointment
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12961
Lenexa, Kansas, United States
Countries
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Other Identifiers
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TV45070-PK-10033
Identifier Type: -
Identifier Source: org_study_id