HealthyPhase 1NCT00972127
Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Study With and Without Application of a Urinary pH Acidification Regimen
A Phase 1 study testing Neramexane in people with Healthy, run by Merz Pharmaceuticals GmbH.
Trial summary
Primary: To assess the influence of acidified urinary pH on the renal excretion of Neramexane Secondary: To assess the influence of acidified urinary pH on the renal excretion of N-OH Neramexane To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH Neramexane under physiological conditions and… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neramexane
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 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 any ethnic 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 subject of childbearing potential must agree to use an effective method of birth control such as sexual abstinence, vasectomised partner, non hormonal IUDs or double contraception methods (e.g., condom with 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 Ammonium Chloride
- 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 tool substances
- Lactating or pregnant female or female planning to become pregnant during study conduct or within 2 months after end of study. Male planning to beget children during study conduct or within 2 months after end of study
- Any contraindications which are indicated in the topically valid SPC for Extin®N: acidosis, gastritis, gastro-intestinal ulcer, hepatic or renal insufficiency, hypokalemia
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- Lack of suitability for the trial
- Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic (acidosis), psychiatric or other disease at screening
- History of malignancy
- Any clinically relevant deviation in clinical or laboratory assessment
- Clinically relevant abnormalities in the 12-lead ECG which in the discretion of the investigator and the Merz scientific expert might affect the study objectives
- 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
- Clinically relevant chronic or acute infections
- Acute or chronic disease, especially psychiatric or neurologic disorders
- Current evidence of hypokalemia (= below lower limit of laboratory normal range plus 0.3 mmol/l as safety margin)
- History of alcohol or drug dependence within the last 2 years
- Alcohol consumption averaging more than 40 g for male and more than 20 g for female subject 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. acute inflammations, gastrointestinal disease, cholecystectomy, resection of small or large intestine, etc.)
- Use of any prescribed medication for four weeks prior to the first administration of IMP.
- Regular use of over-the-counter [OTC] 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
- Special diet, e.g. vegetarian
- Female subject who employed any form of hormonal contraception within 2 months prior to Day 1 (e.g. oral contraceptives, hormone releasing intrauterine contraceptive devices [IUDs], etc.)
- Consume 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 of more than 450 mL within 60 days prior to Day 1
- Positive pregnancy test, if female
- Positive drug screen or alcohol test
- Administrative reasons
- Lack of willingness or inability to co-operate adequately
- Employee or direct relative of an employee of the CRO or Merz Pharmaceuticals GmbH
- Lack of ability or willingness to give informed consent
- Vulnerable subject (e.g. person kept in detention)
- Anticipated non-availability for study visits/procedures
- Inability to follow study procedures and investigator instructions adequately
About this study
Official title: Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Open-Label, Randomized, Single Center, Multiple Dose, 2-Period, 2-Sequence, Crossover Study With and Without Application of a Urinary pH Acidification Regimen
Primary:
- To assess the influence of acidified urinary pH on the renal excretion of Neramexane
Secondary:
- To assess the influence of acidified urinary pH on the renal excretion of N-OH Neramexane
- To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH Neramexane under physiological conditions and under the conditions of urine acidification
- To assess safety and tolerability of a repeated dose treatment of Neramexane under physiological conditions and under the conditions of urine acidification
- Conditions
- Healthy
- Being tested
- Neramexane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeramexaneDrug
25 mg or 2x25mg tablets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startOct 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 HealthyStudies 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
- Treatment
- Intervention model
- Crossover
- 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
- NCT00972127
- Sponsor's protocol ID
- MRZ 92579/TI/1004
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 7 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Open-Label, Randomized, Single Center, Multiple Dose, 2-Period, 2-Sequence, Crossover Study With and Without Application of a Urinary pH Acidification Regimen
- ClinicalTrials.gov ID
- NCT00972127
- Acronym / sponsor ID
- MRZ 92579/TI/1004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Sep 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 influence of acidified urinary pH on the renal excretion of Neramexane
Secondary:
- To assess the influence of acidified urinary pH on the renal excretion of N-OH Neramexane
- To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH Neramexane under physiological conditions and under the conditions of urine acidification
- To assess safety and tolerability of a repeated dose treatment of Neramexane under physiological conditions and under the conditions of urine acidification
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult subject of any ethnic 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 subject of childbearing potential must agree to use an effective method of birth control such as sexual abstinence, vasectomised partner, non hormonal IUDs or double contraception methods (e.g., condom with spermicide cream)
Key exclusion criteria (41 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 Ammonium Chloride
- 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 tool substances
- Lactating or pregnant female or female planning to become pregnant during study conduct or within 2 months after end of study. Male planning to beget children 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 |
|---|---|---|
| Neramexane25 mg or 2x25mg tablets | 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 7 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neramexane in people with Healthy, run by Merz Pharmaceuticals GmbH.
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 41 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 7 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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 7 Feb 2011.