NCT01723618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

Same day

First QC Date

November 1, 2012

Last Update Submit

November 28, 2012

Conditions

Abdominal Aortic Aneurisms

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Dose linearity

    Pre-dose and until 12 hours post-dose

  • Potential for accumulation

    Pre-dose untill 12 hours post-dose

Study Arms (3)

CRD007 10 mg

EXPERIMENTAL

CRD007, 10 mg tablet, single dose

Drug: CRD007

CRD007 25 mg

EXPERIMENTAL

CRD007, 25 mg tablet, single dose

Drug: CRD007

CRD007 40 mg

EXPERIMENTAL

CRD007, 40 mg tablet, single dose

Drug: CRD007

Interventions

CRD007DRUG
CRD007 10 mgCRD007 25 mgCRD007 40 mg

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Infra-renal abdominal aortic aneurysm

You may not qualify if:

  • Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vascular Surgery Viborg Hospital

Viborg, Denmark, 8800, Denmark

Location

Study Officials

  • Nikolaj F Groendal, MD

    Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 8, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

DK(1)