Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

Abdominal Aortic Aneurisms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723618
• Other study ID #: Cardoz-005
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2012
• Last updated: November 28, 2012
• Start date: November 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: RSPR Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abdominal Aortic Aneurisms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Drug:
• CRD007

Locations

Country	Name	City	State
Denmark	Department of Vascular Surgery Viborg Hospital	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
RSPR Pharma AB

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Dose linearity	Evaluation of dose linearity in the dose range 10 - 40 mg	Pre-dose and until 12 hours post-dose	No
Secondary	Potential for accumulation	To estimate the accumulation of CRD007 in the dose range 10 - 40 mg	Pre-dose untill 12 hours post-dose	No