Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease
This study is a Phase 2, open-label study to assess the pharmacokinetics and safety of AA4500 0.58 mg in men with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug. Two injections will be administered 24 hours apart.
Subjects will be admitted to the study unit the day before the first injection of AA4500 (Day -1) and will remain in the study unit until after the PK sample is collected after investigator penile plaque modeling on Day 3. Subjects will return to the study unit on Day 4, Day 8, and Day 29 for follow-up pharmacokinetic and safety assessments.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Open-Label Study to Assess the Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease|
- Composite of Pharmacokinetic parameters (in subjects who have quantifiable plasma concentrations) following a single injection and a second injection of AA4500 into the Peyronie's plaque. [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 8 and Day 29. ] [ Designated as safety issue: No ]
The following pharmacokinetic parameters will be determined for each subject who has quantifiable plasma concentrations from the 24 hour period following Injection 1: maximum drug concentration (Cmax), time to maximum drug concentration (Tmax), area under the curve from zero to 24 hours (AUC0-24), and AUC0-tlast, where tlast is the last time with quantifiable concentrations.
The following pharmacokinetic parameters will be determined for each subject who has quantifiable plasma concentrations from the 24 hour period following Injection 2: Cmax, Tmax, AUC0-24, and AUC0-tlast.
|Study Start Date:||September 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
collagenase clostridium histolyticum
Two injections of AA4500 0.58 mg
Other Name: XIAFLEX, XIAPEX
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430169
|United States, California|
|Martin Gelbard, MD Inc.|
|Burbank, California, United States, 91505|
|Study Director:||Gregory J. Kaufman, MD||Auxilium Pharmaceuticals, Inc|