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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359605
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : December 20, 2011
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: varespladib methyl Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Primary Completion Date : July 2011
Study Completion Date : July 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: varespladib methyl Drug: varespladib methyl
500 mg oral suspension


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359605


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

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01359605     History of Changes
Other Study ID Numbers: AN-CVD2215
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Anthera Pharmaceuticals:
ADME
Healthy volunteers

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