Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)

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 Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurisms
• Intervention / Treatment: Drug: CRD007

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Department of Vascular Surgery Viborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRD007 10 mg; CRD007, 10 mg tablet, single dose	Drug: CRD007
Experimental: CRD007 25 mg; CRD007, 25 mg tablet, single dose	Drug: CRD007
Experimental: CRD007 40 mg; CRD007, 40 mg tablet, single dose	Drug: CRD007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics - maximum plasma concentration (Cmax)	Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured	Pre-dose and until 12 hours post-dose
Pharmacokinetics - time to maximum plasma concentration (tmax)	Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured.	Pre-dose til 12 hours post-dose
Pharmacokinetics - Area under the plasma concentration curve (AUC)	Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured.	Pre-dose until 12 hours post-dose
Pharmacokinetics - elimination half life (t1/2)	Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured	pre-dose until 12 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose linearity	Evaluation of dose linearity in the dose range 10 - 40 mg	Pre-dose and until 12 hours post-dose
Potential for accumulation	To estimate the accumulation of CRD007 in the dose range 10 - 40 mg	Pre-dose untill 12 hours post-dose

Collaborators and Investigators

• Sponsor: RSPR Pharma AB
• Investigators: Principal Investigator: Nikolaj F Groendal, MD, Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Estimate): November 29, 2012
• Last Update Submitted That Met QC Criteria: November 28, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: Cardoz-005