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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01359579
First received: May 19, 2011
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Drug: varespladib methyl
Phase 1

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

Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function [ Time Frame: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety measures to include adverse events and changes in clinical laboratory results [ Time Frame: From admistration of study drug through follow-up on Day 8 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with mild renal impairment Drug: varespladib methyl
Single oral 500 mg dose
Experimental: Subjects with moderate renal impairment Drug: varespladib methyl
Single oral 500 mg dose
Experimental: Subjects with normal renal function Drug: varespladib methyl
Single oral 500 mg dose
Experimental: Subjects with severe renal impairment Drug: varespladib methyl
Single oral 500 mg dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359579

Locations
United States, Florida
Investigator Site 101
Orlando, Florida, United States, 32809
United States, Minnesota
Investigator Site 102
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Investigator Site 103
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01359579     History of Changes
Other Study ID Numbers: AN-CVD2213
Study First Received: May 19, 2011
Last Updated: March 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
renal impairment
phase 1
healthy volunteers

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Varespladib methyl
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phospholipase A2 Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014