NCT01359579

A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function

A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	varespladib methyl	Single oral 500 mg dose

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2011-05-25
• Last updated: 2012-03-20

Locations

3 sites across 1 country: United States