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OpenTrials
Completed

NCT Number: NCT02215941

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 12961

Lenexa, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TV-45070

Drug

TV-45070 8% ointment

Placebo

Drug

Placebo

Primary outcomes

  1. Plasma concentrations

    Time frame: Day 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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