Abdominal Aortic AneurismsPhase 1NCT01723618
Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.
A Phase 1 study testing CRD007 in people with Abdominal Aortic Aneurisms, run by RSPR Pharma AB at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurisms
- What is being tested?
- CRD007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infra-renal abdominal aortic aneurysm
Who cannot join
- Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Vascular Surgery Viborg Hospital
Viborg, Denmark, 8800
About this study
Official title: An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)
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.
- Conditions
- Abdominal Aortic Aneurisms
- Being tested
- CRD007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD007Drug
| Study group | Role | What they receive |
|---|---|---|
| CRD007 10 mg | Experimental | CRD007, 10 mg tablet, single dose Receives: Drug: CRD007 |
| CRD007 25 mg | Experimental | CRD007, 25 mg tablet, single dose Receives: Drug: CRD007 |
| CRD007 40 mg | Experimental | CRD007, 40 mg tablet, single dose Receives: Drug: CRD007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - maximum plasma concentration (Cmax)
Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured
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.
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.
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
Measured: pre-dose until 12 hours post-dose
Secondary outcomes (2)
Dose linearity
Evaluation of dose linearity in the dose range 10 - 40 mg
Measured: Pre-dose and until 12 hours post-dose
Potential for accumulation
To estimate the accumulation of CRD007 in the dose range 10 - 40 mg
Measured: Pre-dose untill 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurismsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSPR Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikolaj F Groendal, MD, Principal investigator, Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723618
- Sponsor's protocol ID
- Cardoz-005
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)
- ClinicalTrials.gov ID
- NCT01723618
- Acronym / sponsor ID
- Cardoz-005
- Conditions
- Abdominal Aortic Aneurisms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- RSPR Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRD007 10 mg | Experimental | Drug: CRD007CRD007, 10 mg tablet, single dose |
| CRD007 25 mg | Experimental | Drug: CRD007CRD007, 25 mg tablet, single dose |
| CRD007 40 mg | Experimental | Drug: CRD007CRD007, 40 mg tablet, single dose |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infra-renal abdominal aortic aneurysm
Key exclusion criteria (1 listed)
- Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD007 | Drug | CRD007 10 mg, CRD007 25 mg, CRD007 40 mg |
Primary outcome
Pharmacokinetics - maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: pre-dose until 12 hours post-dose
Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured
2 secondary outcomes
Dose linearity
Time frame: Pre-dose and until 12 hours post-dose
Potential for accumulation
Time frame: Pre-dose untill 12 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaj F Groendal, MD principal investigator
Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRD007 in people with Abdominal Aortic Aneurisms, run by RSPR Pharma AB at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - maximum plasma concentration (Cmax) (time frame: Pre-dose and until 12 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.