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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723618

Enrollment

Registered

2012-11-08

Start date

2012-11-30

Completion date

2012-11-30

Last updated

2012-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurisms

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.

Interventions

DRUGCRD007

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026