Advertisement

Topics

Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects

2014-08-27 03:19:17 | BioPortfolio

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.

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 Assignment, Masking: Double Blind (Subject, Caregiver)

Conditions

Healthy Subjects

Intervention

Neramexane

Location

Parexel International GmbH
Berlin
Germany
14050

Status

Recruiting

Source

Merz Pharmaceuticals GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:17-0400

Clinical Trials [1423 Associated Clinical Trials listed on BioPortfolio]

Open, Single Center, Three Periods, Fixed Sequence Design Study on the Effects of Clopidogrel Co-administration on the Pharmacokinetics of Neramexane

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: T...

Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH 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 exc...

Study Analyzing the Effect of Rifampicin Administration on the Pharmacokinetics of Neramexane Mesylate

Primary Objectives: • Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by repeated dose Rifampicin (600 mg/day) co-administration on the single-dose ...

Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus

The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a...

The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease

Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between...

PubMed Articles [6688 Associated PubMed Articles listed on BioPortfolio]

Dynamical Hurst analysis identifies EEG channel differences between PTSD and healthy controls.

We employ a time-dependent Hurst analysis to identify EEG signals that differentiate between healthy controls and combat-related PTSD subjects. The Hurst exponents, calculated using a rescaled range a...

Nasal airflow resistance measured by rhinomanometry in a healthy population of China.

Although nasal congestion is among the most common symptoms in subjects suffering from nasal diseases, relatively few data on normal airflow resistance are available for reference, especially in healt...

Voluntary breath-holding duration in healthy subjects with obesity: role of peripheral chemosensitivity to carbon dioxide.

The present study aimed to explore the peripheral chemoreflex sensitivity in healthy subjects with high body mass index (BMI).

Percentages of PD-1+CD4+T cells and PD-L1+DCs are increased and sPD-1 level is elevated in patients with immune thrombocytopenia.

The present study is to measure the expression of programmed death (PD)-1 / programmed death ligand-1 (PD-L1) negative costimulatory molecules, soluble format sPD-1 in patients with immune thrombocyto...

Pharmacokinetics and Safety of Bazedoxifene in Hepatically Impaired and Healthy Postmenopausal Women.

Bazedoxifene, a selective estrogen receptor modulator with proestrogenic effects on bone and lipid metabolism and antiestrogenic effects on the breast and endometrium, is a treatment option for osteop...

Medical and Biotech [MESH] Definitions

Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.

More From BioPortfolio on "Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial