Clinical Trial: Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

This study is a Phase 2, open-label study to assess the pharmacokinetics (PK) 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.Pharmacokinetic plasma samples will be collected at predetermined time points before (15 minutes pre-injection) and after each injection on Day 1 and Day 2 (5,10, 20, 30 minutes and 1,2,3,4,8,12 hours after), and on Days 3, 4, 8, and 29.Plasma levels for AUX-I (clostridial type I collagenase) and AUX-II (clostridial type II collagenase) will be determined.


Detailed Summary:
Sponsor: Endo Pharmaceuticals

Current Primary Outcome:

  • AUX-I Cmax After Injection 1 [ Time Frame: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) ]
    Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
  • AUX-II Cmax After Injection 1 [ Time Frame: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) ]
    Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
  • AUX-I AUC0-tlast After Injection 1 [ Time Frame: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) ]
    Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
  • AUX-II AUC0-tlast After Injection 1 [ Time Frame: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, a

    Original Primary Outcome: 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. ]

    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.



    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Endo Pharmaceuticals

    Dates:
    Date Received: September 6, 2011
    Date Started: September 2011
    Date Completion:
    Last Updated: September 7, 2016
    Last Verified: July 2016