Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

Phase 1

Completed

• Conditions: Abdominal Aortic Aneurisms
• Interventions: Drug: CRD007

• Registration Number: NCT01723618
• Lead Sponsor: RSPR Pharma AB

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-08
• Last Update Submitted: 2012-11-28
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRD007 10 mg	CRD007	CRD007, 10 mg tablet, single dose
CRD007 25 mg	CRD007	CRD007, 25 mg tablet, single dose
CRD007 40 mg	CRD007	CRD007, 40 mg tablet, single dose

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Vascular Surgery Viborg Hospital; 🇩🇰 Viborg, Denmark