A Single Center, Open-Label Study to Quantify Metabolites of [14C]-Neramexane in Plasma and Urine in Healthy Male Subjects

Merz Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Metabolism of Neramexane

Treatments

Drug: Neramexane

Study type

Interventional

Funder types

Industry

Identifiers

NCT01109680

MRZ 92579-1048-0

Details and patient eligibility

About

A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and urine in Healthy Male Subjects

Enrollment

8 estimated patients

Sex

Male

Ages

55 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.)
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