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

NCT01109680 | Completed Phase 1

• 1 other identifier: MRZ 92579-1048-0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolism of Neramexane

Outcome Measures

Primary Outcomes (1)

• Metabolite Profiling

Study Arms (1)

14 C labelled Neramexane, capsule

EXPERIMENTAL

Drug: Neramexane

Interventions

Neramexane DRUG

Multiple dose Neramexane followed by single dose 14C Neramexane

14 C labelled Neramexane, capsule

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

SGS Life Science Services

Antwerp, 2060, Belgium

Location

MeSH Terms

Interventions

neramexane

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 8, 2011

Record last verified: 2010-04

Locations

BE (1)