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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215941
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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
Pharmacokinetics Drug: TV-45070 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: 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
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

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




Primary Outcome Measures :
  1. Plasma concentrations [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Drug level in skin [ Time Frame: Days 1, 8, 15, 22, 29 ]
  2. Excretion of drug in urine [ Time Frame: Day 8 ]
  3. Identification of metabolites in blood [ Time Frame: Days 8, 10 ]
  4. Identification of metabolites in urine [ Time Frame: Day 8 ]
  5. Identification of metabolites in skin [ Time Frame: Days 1, 8, 15, 22, 29 ]
  6. Intraepidermal nerve fiber density in skin [ Time Frame: Days 1, 8, 15, 29 ]
  7. Percentage of Participants with Adverse Events [ Time Frame: 10 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215941


Locations
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United States, Kansas
Teva Investigational Site 12961
Lenexa, Kansas, United States
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT02215941    
Other Study ID Numbers: TV45070-PK-10033
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015