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

• Sponsor: Anthera Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01359605
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 6.1

Study Details

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
• Actual Enrollment: 6 participants
• Allocation: N/A
• 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: Jun 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 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 [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

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Anthera Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthera Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01359605
• Other Study ID Numbers: AN-CVD2215
• First Posted: May 25, 2011
• Last Update Posted: Dec 20, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Anthera Pharmaceuticals: ADME; Healthy volunteers
• Additional relevant MeSH terms: Varespladib methyl

Study Results

No Results Posted as of Dec 20, 2011