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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: TV-45070; Drug: Placebo

• Registration Number: NCT02215941
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TV-45070 21%	TV-45070	twice daily topical application to 21% body surface area for 7.5 days (15 applications)
TV-45070 53%	TV-45070	twice daily topical application to 53% body surface area for 7.5 days (15 applications)
TV-45070 7%	TV-45070	twice daily topical application to 7% body surface area for 7.5 days (15 applications)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Plasma concentrations	Day 8

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Teva Investigational Site 12961; 🇺🇸 Lenexa, Kansas, United States