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

NCT00955760 | Completed Phase 1

• 1 other identifier: MRZ 92579/TI/1003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 pharmacokinetics of Neramexane. Secondary Objectives:
• To assess safety and tolerability of Neramexane single dose treatment alone and co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.

Conditions

Healthy

Keywords

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, who is able to read, to write and fully understand German language
• Aged 18 to 45 years (inclusive)
• BMI of 18-28 kg/m2 (inclusive) and a body weight of 50-90 kg (inclusive)
• 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, e.g., condom and spermicide cream

You may not qualify if:

• Safety concerns
• History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/Amantadine and their derivatives
• History of clinically relevant allergy or known hypersensitivity to Rifampicin or other rifamycines
• History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or the metabolic inducer
• Exposure to another investigational agent within the last two months before Day 1 of Period 1
• Lactating or pregnant females or females planning to become pregnant during study conduct or within 2 months after end of study. Males planning to beget children during study conduct or within 2 months after end of study
• Any contraindications which are indicated in the topically valid SPC for EREMFAT®: severe hepatic impairment like obstructive jaundice, hepatitis, hepatic cirrhosis
• 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

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: August 6, 2009
• First Posted: August 10, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 8, 2011

Record last verified: 2009-08

Locations

DE (1)