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

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: TV-45070; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02215941

TV45070-PK-10033

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

45 participants in 4 patient groups, including a placebo group

TV-45070 7%

Experimental group

Description:

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

Treatment:

Drug: TV-45070

TV-45070 21%

Experimental group

Description:

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

Treatment:

Drug: TV-45070

TV-45070 53%

Experimental group

Description:

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

Treatment:

Drug: TV-45070

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo