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

NCT02215941 | Completed Phase 1

• 1 other identifier: TV45070-PK-10033
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations

  Day 8

Secondary Outcomes (7)

• 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

Study Arms (4)

TV-45070 7%

EXPERIMENTAL

twice daily topical application to 7% body surface area for 7.5 days (15 applications)

Drug: TV-45070

TV-45070 21%

EXPERIMENTAL

twice daily topical application to 21% body surface area for 7.5 days (15 applications)

Drug: TV-45070

TV-45070 53%

EXPERIMENTAL

twice daily topical application to 53% body surface area for 7.5 days (15 applications)

Drug: TV-45070

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TV-45070 DRUG

TV-45070 8% ointment

TV-45070 21%; TV-45070 53%; TV-45070 7%

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (1)

Teva Investigational Site 12961

Lenexa, Kansas, United States

Location

MeSH Terms

Interventions

TV-45070

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 13, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

US (1)