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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01359579
• Other study ID #: AN-CVD2213
• Status: Terminated
• Phase: Phase 1
• First received: May 19, 2011
• Last updated: March 19, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2012
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.

• Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae

Exclusion Criteria:

• Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk

• Evidence of significant respiratory, gastrointestinal or hepatic disease at screening

• Positive screen for hepatitis B surface antigen, or HIV

• Positive test in drugs of abuse screens or alcohol on admission to the clinic

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• varespladib methyl
Single oral 500 mg dose

Locations

Country	Name	City	State
United States	Investigator Site 103	Knoxville	Tennessee
United States	Investigator Site 102	Minneapolis	Minnesota
United States	Investigator Site 101	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function		PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose	No
Secondary	Safety measures to include adverse events and changes in clinical laboratory results		From admistration of study drug through follow-up on Day 8	No