Changes in the Renal Excretion of Neramexane by Acidification of Urinary pH Study With and Without Application of a Urinary pH Acidification Regimen

NCT00972127 | Completed Phase 1

• 1 other identifier: MRZ 92579/TI/1004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 excretion of N-OH Neramexane
• To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH Neramexane under physiological conditions and under the conditions of urine acidification
• To assess safety and tolerability of a repeated dose treatment of Neramexane under physiological conditions and under the conditions of urine acidification

Conditions

Healthy

Interventions

Neramexane DRUG

25 mg or 2x25mg tablets

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 any ethnic 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 subject of childbearing potential must agree to use an effective method of birth control such as sexual abstinence, vasectomised partner, non hormonal IUDs or double contraception methods (e.g., condom with 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 Ammonium Chloride
• 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 tool substances
• Lactating or pregnant female or female planning to become pregnant during study conduct or within 2 months after end of study. Male 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 Extin®N: acidosis, gastritis, gastro-intestinal ulcer, hepatic or renal insufficiency, hypokalemia
• Lack of suitability for the trial
• Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic (acidosis), psychiatric or other disease at screening
• History of malignancy
• Any clinically relevant deviation in clinical or laboratory assessment
• Clinically relevant abnormalities in the 12-lead ECG which in the discretion of the investigator and the Merz scientific expert might affect the study objectives
• 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
• Clinically relevant chronic or acute infections
• Acute or chronic disease, especially psychiatric or neurologic disorders

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

MeSH Terms

Interventions

neramexane

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 7, 2011

Record last verified: 2009-09