Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
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
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of \[14C\]varespladib methyl.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Jun 2011
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 20, 2011
December 1, 2011
1 month
May 19, 2011
December 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Study Arms (1)
varespladib methyl
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Lincoln, Nebraska, 68502, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
May 25, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 20, 2011
Record last verified: 2011-12