Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Healthy Adult Subjects

In brief

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.

Key facts

Study ID

NCT01366326

Run by

Bausch Health Americas, Inc.

People needed

20

Starts

2010-07-01

Expected to finish

2010-08-01

Last updated by the study team

2019-11-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Non-smoker
• Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).

You may not qualify if…

• 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.

Where it is running

• Progenics Pharmaceuticals, Inc. — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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