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NCT01430169 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease
A Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01430169: Completed Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT01430169 is a Phase 2 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01430169, a Phase 2 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- BIOLOGICAL AA4500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01430169 record still lists
NCT01430169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which AA4500 is the first listed.
NCT01430169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01430169 about?
NCT01430169 is a clinical study titled "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 (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. S...
What is the current status of trial NCT01430169?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01430169?
The interventions under investigation include: AA4500 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01430169?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01430169's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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