Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01359605
First received: May 19, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of [14C]varespladib methyl.


Condition Intervention Phase
Healthy Volunteers
Drug: varespladib methyl
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-Label, Single-Dose, Study to Assess the Metabolism and Elimination of Varespladib After Oral Administration of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples [ Time Frame: 1 hour prior to drug, and post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, and 120 hours after drug ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: varespladib methyl Drug: varespladib methyl
500 mg oral suspension

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedure
  • Healthy males, 19 to 55 years of age
  • Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion Criteria:

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, or vital signs at baseline in the opinion of the investigator
  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: NCT01359605

Locations
United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01359605     History of Changes
Other Study ID Numbers: AN-CVD2215
Study First Received: May 19, 2011
Last Updated: December 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
ADME
Healthy volunteers

Additional relevant MeSH terms:
Varespladib methyl
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014