Clinical Trial: Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Open Label Pharmacokinetic Study of Granexin® Gel in Patients With Venous Leg Ulcers

Brief Summary: The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers.

Detailed Summary:

The objective of this study is to ascertain the systemic exposure of the active ingredient in Granexin® gel (aCT1 peptide) after topical application to venous leg ulcers using pharmacokinetic analysis. It is planned that a total of 16 patients with venous leg ulcers will receive Granexin® gel treatment plus standard of care in this one arm study. The study includes a screening period (1 week) and a treatment period (1 week) which occur sequentially for a given patient.The baseline day, which demarcates the beginning of the treatment period, is the designated as Day 0. Screening procedures are initially conducted on Day -7.

A target venous leg ulcer is identified at screening and patient eligibility is confirmed at screening and then again at the beginning of the Day 0 (baseline) visit. A patient enrolled in the study may have multiple ulcers on the same or either leg; in this case, all ulcers will be treated with Granexin® gel, but only ulcer(s) meeting the following criteria will be designated as the target ulcer(s) and will determine eligibility: >15cm2 of least 4 weeks duration in post debridement.

The treatment period for a given patient begins on Day 0 and ends one week later; the last scheduled day of the treatment period is designated as Day 7. During each treatment period, each patient is scheduled to receive topical treatment with study drug gel (3 applications total) administered by study staff at scheduled study site visits at each of the following time points: Day 0 , Day 3, and Day 7. All patients, regardless of treatment assignment, also receive standard-of-care treatment at scheduled study visits during the treatment period.

Study drug pre-application blood samples will be collected from each patient at Day 0, Day 3, and Day 7. Study drug po
Sponsor: FirstString Research, Inc.

Current Primary Outcome:

  • Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in plasma [ Time Frame: Day 0 ]
  • Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in plasma [ Time Frame: Day 3 ]
  • Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in plasma [ Time Frame: Day 7 ]


Original Primary Outcome: Evaluation of systemic exposure of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) in plasma [ Time Frame: Day 0: pre-Granexin application; post-Granexin application at 5 min, 30 min, 1 hr, 4 hrs, 8 hrs; Day 3: pre-Granexin application; Day 7: pre-Granexin application; post-Granexin application at 5 min, 30 min, 1 hr, 4 hrs, 8 hrs ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FirstString Research, Inc.

Dates:
Date Received: January 8, 2016
Date Started: September 2015
Date Completion: July 2017
Last Updated: March 3, 2017
Last Verified: March 2017