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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01723618
Other study ID # Cardoz-005
Secondary ID
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


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