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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. 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.
Interventions
- BIOLOGICAL AA4500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01430169
The ClinicalTrials.gov registry entry for NCT01430169 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AA4500 is the first listed.
NCT01430169 reports 0 study locations.
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.
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