Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
This study has been completed.
Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01359605
First received: May 19, 2011
Last updated: December 16, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of [14C]varespladib methyl.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: varespladib methyl |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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 |
Further study details as provided by Anthera Pharmaceuticals:
Primary Outcome Measures:
- Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples [ Time Frame: 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 ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | June 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: varespladib methyl |
Drug: varespladib methyl
500 mg oral suspension
|
Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01359605 History of Changes |
| Other Study ID Numbers: | AN-CVD2215 |
| Study First Received: | May 19, 2011 |
| Last Updated: | December 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anthera Pharmaceuticals:
|
ADME Healthy volunteers |
ClinicalTrials.gov processed this record on May 21, 2013