Metabolic Clearance RatePhase 4NCT00260247
Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
A Phase 4 study testing carbamazepine oxcarbazepine in people with Metabolic Clearance Rate, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Clearance Rate
- What is being tested?
- carbamazepine oxcarbazepine
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2005to Oct 2006
- Phase
- Phase 4
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 30
- Non smoker
- No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
- Informed consent
Who cannot join
- signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
- mental disease
- participation in another clinical trial involving drugs with 3 months of randomization
- donation of more than 500 mL blood within 3 months of randomization
- intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.
- Conditions
- Metabolic Clearance Rate
- Being tested
- carbamazepine oxcarbazepine
- Keywords
- CYP3A4, Induction, Oxcarbazepine, Carbamazepine, Quinidine, Human, In vivo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbamazepine oxcarbazepineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Formation clearance of 3-hydroxyquinidine
Secondary outcomes (1)
Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Clearance RateStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Agency, Novartis
- Investigators
- Per Damkier, MD, Ph.D., Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260247
- Sponsor's protocol ID
- AKF-315
- Status last verified
- Mar 2005
- First submitted
- 28 Nov 2005
- Last updated
- 22 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
- ClinicalTrials.gov ID
- NCT00260247
- Acronym / sponsor ID
- AKF-315
- Conditions
- Metabolic Clearance Rate
- Keywords
- CYP3A4, Induction, Oxcarbazepine, Carbamazepine, Quinidine, Human, In vivo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Research Agency, Novartis
- Study start
- Apr 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Dec 2005 (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.
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI < 30
- Non smoker
- No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
- Informed consent
Key exclusion criteria (5 listed)
- signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
- mental disease
- participation in another clinical trial involving drugs with 3 months of randomization
- donation of more than 500 mL blood within 3 months of randomization
- intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
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 |
|---|---|---|
| carbamazepine oxcarbazepine | Drug | – |
Primary outcome
Formation clearance of 3-hydroxyquinidine
1 secondary outcome
Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
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 22 Apr 2015.
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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.
Per Damkier, MD, Ph.D. principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbamazepine oxcarbazepine in people with Metabolic Clearance Rate, run by Odense University Hospital 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 4 inclusion and 5 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 22 Apr 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Formation clearance of 3-hydroxyquinidine. 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 22 Apr 2015.