Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: TV-45070 7% twice daily topical application to 7% body surface area for 7.5 days (15 applications) |
Drug: TV-45070
TV-45070 8% ointment
|
Experimental: TV-45070 21% twice daily topical application to 21% body surface area for 7.5 days (15 applications) |
Drug: TV-45070
TV-45070 8% ointment
|
Experimental: TV-45070 53% twice daily topical application to 53% body surface area for 7.5 days (15 applications) |
Drug: TV-45070
TV-45070 8% ointment
|
Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Plasma concentrations [Day 8]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male and/or female subjects aged 18 to 50 years
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Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
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Able and willing to provide written informed consent.
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Able and willing to comply with all study procedures and restrictions.
Exclusion Criteria:
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History or evidence of clinically significant illness or surgery
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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.
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History of significant drug or alcohol abuse
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Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
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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.
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Pregnant or nursing females
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Shaving or waxing the planned study treatment application area within 7 days prior Day
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Laser hair removal of the planned study treatment application area within 2 months prior to Day 1.
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other criteria apply, please contact the investigator for more information
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Teva Investigational Site 12961 | Lenexa | Kansas | United States |
Sponsors and Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
- Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TV45070-PK-10033