NCT00528931

A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 \[NCT00528606\]and AUX-CC-859 \[NCT00533273\]) and 7 non-pivotal studies were evaluated.

Conditions

• Dupuytren's Contracture

Interventions

Type	Name	Description
BIOLOGICAL	collagenase clostridium histolyticum	Single dose of AA4500 0.58 mg into the cord

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-12-01
• Completion: 2008-03-01
• First posted: 2007-09-12
• Last updated: 2017-10-05
• Results posted: 2012-08-20

Locations

1 site across 1 country: United States