Healthy SubjectsPhase 1NCT00936026
Open, Single Center, Three Periods, Fixed Sequence Design Study on the Effects of Clopidogrel Co-administration on the Pharmacokinetics of Neramexane
A Phase 1 study testing Neramexane in people with Healthy Subjects, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
Primary: To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day) co-administration on the single-dose pharmacokinetics of Neramexane Secondary: To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single-dose with a Clopidogrel… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Neramexane
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Dec 2009
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subject of white origin, who is able to read, to write and fully understand German language
- Aged 18 to 45 years
- BMI of 18-28 kg/m2 and a body weight of 50-90 kg
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study. Female subjects of childbearing potential must agree to use a highly effective method of birth control defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly such as sexual abstinence, vasectomised partner, non hormonal IUDs, double barrier methods, for instance, e.g. condom and spermicide cream.
Who cannot join
- History of clinically relevant allergy or known hypersensitivity to Neramexane/ Memantine/Amantadine and their derivatives
- History of clinically relevant allergy or known hypersensitivity to Clopidogrel
- Exposure to another investigational agent within the last two months before Day 1 of Period 1
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or the metabolic inhibitor
- Lactating or pregnant females or females planning to become pregnant during study conduct or within 2 months after end of study
- Any contraindications which are indicated in the topically valid SPC for Plavix®: severe hepatic impairment; active pathological bleeding such as peptic ulcer or intracranial hemorrhage
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- Lack of suitability for the trial:
- Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic or other disease at screening
- History of malignancy
- Any clinically relevant deviation in clinical or laboratory assessment
- ECG abnormalities of clinical relevance, in particular abnormal prolongations of QT/QTc-interval (i.e. QTc ≥ 450 ms, PQ ≥ 220 ms)
- Systolic blood pressure <95 mmHg or >150 mmHg or diastolic blood pressure < 50 mmHg or >90 mmHg in supine position
- Pulse rate <45 or >100 beats per minute
- Chronic or acute clinically relevant infections
- Acute or chronic disease, especially psychiatric or neurologic disorders
- History of alcohol or drug dependence
- Alcohol consumption averaging more than 40 g for male and more than 20 g for female subjects daily within the last year
- Regular caffeine consumption averaging more than 1 L of coffee and/or tea daily or more than 1 L of caffeine-containing lemonades per day within the last year
- Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal products (e.g. cholecystectomy, ulcus, etc.)
- Anticipated donation of spermatocytes or oocytes for medically assisted reproduction techniques [ART] within two months after the last dose of the present study
- Use of any prescribed medication for four weeks prior to the first administration of IMP.
- Regular use of over-the-counter drugs in the 4 weeks prior to the first administration of the IMP
- Occasional use of OTC drugs (except paracetamol, maximum 1 g/day) within the 2 weeks prior to the first administration of the IMP.
- Stable intake of thyroid hormone substitution will be allowed.
- Use of any food, food supplement or medication known to induce or inhibit CYP3A4 or other cytochrome P450 enzymes within two weeks preceding the start of the study (Day 1), e.g. grapefruit, St. John's wort
- Female subjects who employed any form of hormonal contraception within 2 months prior to study Day 1 (e.g. oral contraceptives, hormone releasing intrauterine contraceptive devices [IUDs], etc.)
- Consumption of xanthine derivates (including caffeine) within two days prior to Day 1
- Smoker and user of snuff, nicotine replacement and chewing tobacco
- Previous enrolment into the clinical phase of the current study
- Positive results in any of the serology tests
- Blood donation more than 450 mL within 60 days prior to Day 1
- Positive pregnancy test, if female
- Positive drug screen or alcohol test
Trial locations and contacts
1 site in 1 country.
About this study
Primary:
To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day) co-administration on the single-dose pharmacokinetics of Neramexane
Secondary:
To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single-dose with a Clopidogrel repeated dose treatment
- Conditions
- Healthy Subjects
- Being tested
- Neramexane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeramexaneDrug
Drug-Drug Interaction Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936026
- Sponsor's protocol ID
- MRZ 92579/TI/1002
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 8 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Single Center, Three Periods, Fixed Sequence Design Study on the Effects of Clopidogrel Co-administration on the Pharmacokinetics of Neramexane
- ClinicalTrials.gov ID
- NCT00936026
- Acronym / sponsor ID
- MRZ 92579/TI/1002
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Jul 2009 (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.
Primary:
To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day) co-administration on the single-dose pharmacokinetics of Neramexane
Secondary:
To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single-dose with a Clopidogrel repeated dose treatment
Study design
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult subject of white origin, who is able to read, to write and fully understand German language
- Aged 18 to 45 years
- BMI of 18-28 kg/m2 and a body weight of 50-90 kg
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study. Female subjects of childbearing potential must agree to use a highly effective method of birth control defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly such as sexual abstinence, vasectomised partner, non hormonal IUDs, double barrier methods, for instance, e.g. condom and spermicide cream.
Key exclusion criteria (33 listed)
- History of clinically relevant allergy or known hypersensitivity to Neramexane/ Memantine/Amantadine and their derivatives
- History of clinically relevant allergy or known hypersensitivity to Clopidogrel
- Exposure to another investigational agent within the last two months before Day 1 of Period 1
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or the metabolic inhibitor
- Lactating or pregnant females or females planning to become pregnant during study conduct or within 2 months after end of study
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 |
|---|---|---|
| NeramexaneDrug-Drug Interaction Study | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neramexane in people with Healthy Subjects, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 33 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 8 Feb 2011. 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 Germany. 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.
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 8 Feb 2011.