Status:
COMPLETED
Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02215941
Start Date
August 1 2014
End Date
February 1 2015
Last Update
November 9 2021
Active Locations (1)
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1
Teva Investigational Site 12961
Lenexa, Kansas, United States