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

NCT ID: NCT01359605

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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ADME Healthy volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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varespladib methyl

Group Type EXPERIMENTAL

varespladib methyl

Intervention Type DRUG

500 mg oral suspension

Interventions

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varespladib methyl

500 mg oral suspension

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anthera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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AN-CVD2215

Identifier Type: -

Identifier Source: org_study_id