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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01359605

Run by

Anthera Pharmaceuticals

People needed

6

Starts

2011-06-01

Expected to finish

2011-07-01

Last updated by the study team

2011-12-20

Who can join

Age: 19 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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