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

NCT00936026 | Completed Phase 1

• 1 other identifier: MRZ 92579/TI/1002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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: To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single-dose with a Clopidogrel repeated dose treatment

Conditions

Healthy Subjects

Interventions

Neramexane DRUG

Drug-Drug Interaction Study

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subject of white 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 subjects of childbearing potential must agree to use a highly effective method of birth control defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly such as sexual abstinence, vasectomised partner, non hormonal IUDs, double barrier methods, for instance, e.g. condom and spermicide cream.

You may not qualify if:

• History of clinically relevant allergy or known hypersensitivity to Neramexane/ Memantine/Amantadine and their derivatives
• History of clinically relevant allergy or known hypersensitivity to Clopidogrel
• 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 the metabolic inhibitor
• Lactating or pregnant females or females planning to become pregnant during study conduct or within 2 months after end of study
• Any contraindications which are indicated in the topically valid SPC for Plavix®: severe hepatic impairment; active pathological bleeding such as peptic ulcer or intracranial hemorrhage
• Lack of suitability for the trial:
• Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic or other disease at screening
• History of malignancy
• Any clinically relevant deviation in clinical or laboratory assessment
• 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 \>150 mmHg or diastolic blood pressure \< 50 mmHg or \>90 mmHg in supine position
• Pulse rate \<45 or \>100 beats per minute
• Chronic or acute clinically relevant infections
• Acute or chronic disease, especially psychiatric or neurologic disorders

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

AAIPharma Deutschland gmbH & Co. KG

Neu-Ulm, Bavaria, 89231, Germany

Location

MeSH Terms

Interventions

neramexane

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 8, 2011

Record last verified: 2009-07

Locations

DE (1)