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

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

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


Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01359605

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

Responsible Party: Anthera Pharmaceuticals Identifier: NCT01359605     History of Changes
Other Study ID Numbers: AN-CVD2215
Study First Received: May 19, 2011
Last Updated: December 16, 2011

Keywords provided by Anthera Pharmaceuticals:
Healthy volunteers

Additional relevant MeSH terms:
Varespladib methyl
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on July 19, 2017