Title
Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone
Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers
Phase
Phase 2Lead Sponsor
Bausch Health CompaniesStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Healthy VolunteersIntervention/Treatment
methylnaltrexone ...Study Participants
12This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.
Inclusion Criteria: Must be male or non-pregnant female volunteers Must be 18 to 65 yrs of age Must have no significant active disease states Exclusion Criteria: History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric) Illicit drug users Subjects who received an experimental new drug in the past 30 days Subjects with any laboratory findings outside normal limits