Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects
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MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Body weight ≥40 kg (88 lb)
In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).
History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
History of clinically significant allergies
Positive urine screen for drugs
History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
Prior exposure, allergy or known hypersensitivity to methylnaltrexone
Diagnosis of alcohol or substance dependence within the past 12 months.