Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.

Key facts

Study ID: NCT01367496
Run by: Bausch Health Americas, Inc.
People needed: 6
Starts: 2002-06-01
Expected to finish: 2002-08-01
Last updated by the study team: 2019-11-27

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Subject weight between 60 and 80 kg
Subject a non-smoker
Subject in good physical health, based on history, physical exam, appropriate laboratory and diagnostics tests at screening with no evidence of clinically significant chronic medical condition.

You may not qualify if…

Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids
Subject consuming any prescription medication within the past two weeks, over-the-counter (OTC) products within seven days, any experimental medication within 30 days prior to study screening, or of any drug with a half-life longer then three days within 10 half-lives (>30 days) of screening
Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening
Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.

Where it is running

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

Full record on ClinicalTrials.gov

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