Healthy SubjectsPhase 1NCT00978614
Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects
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 ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Apr 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subject confirmed on the basis of extensive pre-study screening investigations
- Aged 18 to 45, inclusive
- Body mass index [BMI] of 18-28 kg/m² (inclusive) 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 child-bearing potential must agree to use a non-hormonal highly effective method of birth control defined as those which result in a low failure rate when used consistently and correctly, such as sexual abstinence, vasectomized partner, non-hormone releasing intrauterine devices [IUDs].
- A sexually active man, who has not been sterilized surgically, must agree to use together with his female partner a double contraception method during intercourse:
- IUD or hormonal contraception plus condom or diaphragm or spermicide, or
- condom plus diaphragm or observe abstinence during the entire clinical study until the Final Examination.
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 moxifloxacin or any other quinolone antibiotics
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or positive control especially quinine
- Any contraindications which are indicated in the current SPC of Avalox®
- Evidence or (family) history of long QT syndrome
- Exposure to another investigational agent within the last two months before Day -1
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- Lactating or pregnant female, or female planning to become pregnant during study conduct
- Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic (acidosis), psychiatric, neurologic, relevant eye disorder or other diseases at screening
- 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 >140 mmHg or diastolic blood pressure <50 mmHg or >95 mmHg in semi-supine position
- Pulse rate <45 or >100 beats per minute
- History of malignancy
- Any clinically relevant deviation in clinical or laboratory assessment
- Acute or chronic clinically relevant infections
- Current evidence of hypokalemia and/or hypomagnesemia (= below lower limit of laboratory normal range plus 0.3 mmol/L as safety margin)
- History of alcohol or illicit drug abuse
- Alcohol consumption averaging more than 40 g for male and more than 20 g for female subjects daily within the last year
- Alcohol consumption within the last 48 hours prior to Day -1 or illicit drug intake in the 4 weeks prior to Day -1
- 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, resections of small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease severe infections, acute inflammations, etc.)
- Allergy to band aid
- Use of any prescribed drugs in the 4 weeks prior to Day -1
- Regular use of over-the-counter [OTC] drugs (except paracetamol, maximum 1 g/day) in the 4 weeks prior to Day -1
- Occasional use of OTC drugs (except paracetamol, maximum 1 g/day) in the 2 weeks prior to Day -1
- Use of any food, food supplement or medication known to induce or inhibit cytochrome P450 [CYP] 2B6 or any other clinical relevant CYP enzymes within two weeks preceding Day -1 (e.g. grapefruit, St. Johns wort)
- 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
- Female subject who employed any form of hormonal contraception within 2 months prior to study Day -1 (e.g. oral contraceptives, hormone releasing IUDs, etc.)
- Consume of xanthine derivates (including coffee, tea, chocolate, etc.) or quinine containing beverages (Bitter Lemon, Tonic Water, etc.) within two days prior to Day -1
- Smoker
- Previous participation in the drug administration phase of this trial
- Blood donation more than 450 mL within 60 days prior to Day -2
- Positive results in any of the serology tests (Human Immunodeficiency Virus [HIV1/2] antibodies, hepatitis B surface antigen, antibodies against hepatitis C virus)
- Positive pregnancy test
- Positive drug screen or alcohol test
- Excessive sports within 3 days before Day -2
- Sauna within 48 hours before Day -2
- Employee or direct relative of an employee of the CRO or Merz Pharmaceuticals
- Evidence or suspicion that the subject might not comply with the study directives and/or that he/she is not reliable or trustworthy
- Evidence or suspicion that the subject is not willing or unable to understand the information that is given to him/her as part of the informed consent, in particular regarding the risks and discomfort to which he/she would agree to be exposed
- Vulnerable subject (e.g. person kept in detention)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valuation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration) Randomized, Double-Blind, Placebo- and Moxifloxacin-Controlled, Ascending Repeated-Dose, Three-Arm Parallel Design ECG Study in Healthy Adult Subjects
Primary:
- To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
Secondary:
- To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated method will be available for this metabolite) following repeated daily doses of 50 mg (steady state), 75 mg (steady state) and 87.5 mg (steady state).
- To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg repeated-dose treatments when gradually up-titrated in healthy subjects.
- To assess the concentration-QT relationship.
- 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
Dosage form:
25 mg immediate release [IR] tablets (=15.9 mg neramexane free base)
37.5 mg IR tablets (=23.9 mg neramexane free base)
| Study group | Role | What they receive |
|---|---|---|
| Neramexane, Placebo, Moxifloxacin | Experimental | Not described Receives: Drug: Neramexane |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
Measured: steady state, therapeutic dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978614
- Sponsor's protocol ID
- MRZ 92579/TI/1006
- Status last verified
- Feb 2011
- First submitted
- 10 Sep 2009
- Last updated
- 15 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration) Randomized, Double-Blind, Placebo- and Moxifloxacin-Controlled, Ascending Repeated-Dose, Three-Arm Parallel Design ECG Study in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00978614
- Acronym / sponsor ID
- MRZ 92579/TI/1006
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 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 effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
Secondary:
- To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated method will be available for this metabolite) following repeated daily doses of 50 mg (steady state), 75 mg (steady state) and 87.5 mg (steady state).
- To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg repeated-dose treatments when gradually up-titrated in healthy subjects.
- To assess the concentration-QT relationship.
Study design
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neramexane, Placebo, Moxifloxacin | Experimental | Drug: Neramexane |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult subject confirmed on the basis of extensive pre-study screening investigations
- Aged 18 to 45, inclusive
- Body mass index [BMI] of 18-28 kg/m² (inclusive) 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 child-bearing potential must agree to use a non-hormonal highly effective method of birth control defined as those which result in a low failure rate when used consistently and correctly, such as sexual abstinence, vasectomized partner, non-hormone releasing intrauterine devices [IUDs].
Key exclusion criteria (39 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 moxifloxacin or any other quinolone antibiotics
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or positive control especially quinine
- Any contraindications which are indicated in the current SPC of Avalox®
- Evidence or (family) history of long QT syndrome
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 |
|---|---|---|
| NeramexaneDosage form: 25 mg immediate release [IR] tablets (=15.9 mg neramexane free base) 37.5 mg IR tablets (=23.9 mg neramexane free base) | Drug | Neramexane, Placebo, Moxifloxacin |
Primary outcome
To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
Time frame: steady state, therapeutic 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 15 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 8 inclusion and 39 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 15 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.
What does the primary outcome measure?
To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects. (time frame: steady state, therapeutic dose). 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 15 Feb 2011.