Brief Title
Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.
Official Title
An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)
Brief Summary
The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Pharmacokinetics - maximum plasma concentration (Cmax)
Secondary Outcome
Dose linearity
Condition
Abdominal Aortic Aneurisms
Intervention
CRD007
Study Arms / Comparison Groups
CRD007 10 mg
Description: CRD007, 10 mg tablet, single dose
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
November 2012
Completion Date
November 2012
Primary Completion Date
November 2012
Eligibility Criteria
Inclusion Criteria: - Infra-renal abdominal aortic aneurysm Exclusion Criteria: - Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nikolaj F Groendal, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT01723618
Organization ID
Cardoz-005
Responsible Party
Sponsor
Study Sponsor
RSPR Pharma AB
Study Sponsor
Nikolaj F Groendal, MD, Principal Investigator, Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark
Verification Date
November 2012