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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02215941

Enrollment

Registered

2014-08-13

Start date

2014-08-31

Completion date

2015-02-28

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

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.

Interventions

DRUGTV-45070

TV-45070 8% ointment

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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 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

Design outcomes

Primary

Measure	Time frame
Plasma concentrations	Day 8

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026