Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT01430169
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.
Study:
NCT01430169
Study Brief:
Protocol Section:
NCT01430169