Study to Assess the Metabolism and Elimination of [14C]-L... | NCT01359605

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

NCT01359605

Sponsor

Anthera Pharmaceuticals

Status

Completed

Last Update Posted

Dec 20, 2011Estimated

Enrollment

6Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

varespladib methyl

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

May 19, 2011

First Submission Date that Met QC Criteria

May 23, 2011

First Posted Date

May 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2011

Last Update Posted Date

Dec 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
varespladib methyl	Experimental		Drug: varespladib methyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
varespladib methyl	Drug	500 mg oral suspension	varespladib methyl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Lincoln	Nebraska	68502	United States

Intervention Browse Module

MeSH Terms

ID	Term
C545088	varespladib methyl

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided