Metabolism of NeramexanePhase 1NCT01109680
A Single Center, Open-Label Study to Quantify Metabolites of [14C]-Neramexane in Plasma and Urine in Healthy Male Subjects
A Phase 1 study testing Neramexane in people with Metabolism of Neramexane, run by Merz Pharmaceuticals GmbH at 1 site in Belgium.
Trial summary
A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and urine in Healthy Male Subjects Read more about this study
- Who is it for?
- Ages 55 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism of Neramexane
- What is being tested?
- Neramexane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to Jun 2010
- 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 55 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 55 to 65 years inclusive
- BMI of 18-29 kg/m2 (inclusive) and a body weight of ≥50 and ≤90 kg
- All ethnicities, Fitzpatrick type < IV (see appendix 2)
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
- Healthy adult male subject, who is able to read, to write and fully understand Dutch language
Who cannot join
- History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/Amantadine and their derivates
- Exposure to another investigational agent within the last two months before first drug administration
- Administration of radiolabeled substance or exposure to significant radiation (e.g. serial X-ray or CT scans etc.) within the last 12 months. X-rays or spiral CT scans of extremities are allowed.
- Lack of suitability for the study
- Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic, psychiatric, neurologic or other acute or chronic disease
- 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, active gastric ulcers, etc.)
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- Clinically relevant acute or chronic infections, observed within 4 weeks before first drug administration
- History of malignancy, except basal cell carcinoma
- Any clinically relevant deviation in clinical or laboratory assessment as deemed by the investigator
- Abnormalities in the 12-lead ECG (at screening) which in the discretion of the investigator and the Merz scientific expert are clinical relevant or might affect the study objectives
- Systolic blood pressure <95 mmHg or >155 mmHg or diastolic blood pressure < 50 mmHg or >95 mmHg in supine position
- Pulse rate <45 or >100 beats per minute
- History of alcohol or drug dependence
- Alcohol consumption averaging a weekly intake in excess of 21 units of alcohol (one unit of alcohol equals a glass of beer of 300 mL, a glass of wine of 125 mL, or a measure of spirits of 25 mL) within the last year
- Regular large caffeine consumption averaging more than 6 cups of coffee and/or tea per day or more than 1 L of caffeine-containing beverages per day within the last year
- Use of any prescribed medication 4 weeks prior to the first administration of IMP (except paracetamol, maximum 2 g/day). Thyroid hormone substitution will be allowed)
- Regular use of over-the-counter drugs 4 weeks prior to the first administration of the IMP.
- Occasional use of OTC drugs (except paracetamol, maximum 2 g/day) in the 2 weeks prior to the first administration of the IMP
- Use of any food, food supplement or medication known to induce or inhibit CYP3A4 or other cytochrome P450 enzymes within two weeks before first drug administration e.g. grapefruit, St. Johns wort
- Consume of xanthine derivates (including caffeine) within two days before first drug administration
- Smokers or ex-smokers who have stopped for less than 6 months, and user of snuff, nicotine replacement chewing tobacco
- Blood donation more than 450 mL within 60 days before first drug administration
- Positive results in any of the serology tests
- Positive drug screen or alcohol test
- Subject is an employee or direct relative of an employee of the CRO or Merz Pharmaceuticals
- Lack of ability or willingness to give informed consent
- Lack of willingness or inability to co-operate adequately
- Vulnerable subjects (e.g. persons kept in detention)
- Anticipated non-availability for study visits/procedures
Trial locations and contacts
1 site in 1 country.
About this study
A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and urine in Healthy Male Subjects
- Conditions
- Metabolism of Neramexane
- Being tested
- Neramexane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeramexaneDrug
Multiple dose Neramexane followed by single dose 14C Neramexane
| Study group | Role | What they receive |
|---|---|---|
| 14 C labelled Neramexane, capsule | Experimental | Not described Receives: Drug: Neramexane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite Profiling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism of NeramexaneStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109680
- Sponsor's protocol ID
- MRZ 92579-1048-0
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- 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
- A Single Center, Open-Label Study to Quantify Metabolites of [14C]-Neramexane in Plasma and Urine in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01109680
- Acronym / sponsor ID
- MRZ 92579-1048-0
- Conditions
- Metabolism of Neramexane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Apr 2010 (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.
A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and urine in Healthy Male Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14 C labelled Neramexane, capsule | Experimental | Drug: Neramexane |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 55 to 65 years inclusive
- BMI of 18-29 kg/m2 (inclusive) and a body weight of ≥50 and ≤90 kg
- All ethnicities, Fitzpatrick type < IV (see appendix 2)
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
- Healthy adult male subject, who is able to read, to write and fully understand Dutch language
Key exclusion criteria (29 listed)
- History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/Amantadine and their derivates
- Exposure to another investigational agent within the last two months before first drug administration
- Administration of radiolabeled substance or exposure to significant radiation (e.g. serial X-ray or CT scans etc.) within the last 12 months. X-rays or spiral CT scans of extremities are allowed.
- Lack of suitability for the study
- Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic, psychiatric, neurologic or other acute or chronic disease
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 |
|---|---|---|
| NeramexaneMultiple dose Neramexane followed by single dose 14C Neramexane | Drug | 14 C labelled Neramexane, capsule |
Primary outcome
Metabolite Profiling
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.
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 Metabolism of Neramexane, run by Merz Pharmaceuticals GmbH at 1 site in Belgium.
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 5 inclusion and 29 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 Belgium. 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?
Metabolite Profiling. 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 8 Feb 2011.