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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02215941
Collaborator
(none)
45
1
4
6
7.4

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

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
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 :
Aug 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Feb 1, 2015

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

  1. Plasma concentrations [Day 8]

Secondary Outcome Measures

  1. Drug level in skin [Days 1, 8, 15, 22, 29]

  2. Excretion of drug in urine [Day 8]

  3. Identification of metabolites in blood [Days 8, 10]

  4. Identification of metabolites in urine [Day 8]

  5. Identification of metabolites in skin [Days 1, 8, 15, 22, 29]

  6. Intraepidermal nerve fiber density in skin [Days 1, 8, 15, 29]

  7. Percentage of Participants with Adverse Events [10 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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/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

  • 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

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.
Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT02215941
Other Study ID Numbers:
  • TV45070-PK-10033
First Posted:
Aug 13, 2014
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021

Study Results

No Results Posted as of Nov 9, 2021