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

November 5, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States
        • Teva Investigational Site 12961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations
Time Frame: Day 8
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Drug level in skin
Time Frame: Days 1, 8, 15, 22, 29
Days 1, 8, 15, 22, 29
Excretion of drug in urine
Time Frame: Day 8
Day 8
Identification of metabolites in blood
Time Frame: Days 8, 10
Days 8, 10
Identification of metabolites in urine
Time Frame: Day 8
Day 8
Identification of metabolites in skin
Time Frame: Days 1, 8, 15, 22, 29
Days 1, 8, 15, 22, 29
Intraepidermal nerve fiber density in skin
Time Frame: Days 1, 8, 15, 29
Days 1, 8, 15, 29
Percentage of Participants with Adverse Events
Time Frame: 10 Weeks
10 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TV45070-PK-10033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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