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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: varespladib methyl

• Registration Number: NCT01359605
• Lead Sponsor: Anthera Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-25
• Study Start: 2011-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-16
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
varespladib methyl	varespladib methyl	-

Primary Outcome Measures

Name	Time	Method
Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples	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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States