Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
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This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy males between the ages of 18 and 55
Body weight range form 154-220 lbs
No history of clinically significant metabolic disorders.
Any history of low CYP450 2D6 activity
History of alcohol abuse or recreational drugs
History of any clinically significant disease or condition affecting a major organ system
Donation or loss of blood, 60 days proceeding to screening visit.