Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adults

In brief

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.

Key facts

Study ID

NCT01366365

Run by

Bausch Health Americas, Inc.

People needed

28

Starts

2006-10-01

Expected to finish

2006-11-01

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older.
• Subjects who were non-smokers
• Subjects with body weights within range of 70-100 kg (154-220 lbs).

You may not qualify if…

• Subjects who had previously been exposed to MNTX
• Subjects with a history of vasovagal episodes or fainting within the past five years
• Subjects with a history of psychiatric or neurologic disorder
• Subjects with a history of narrow-angle glaucoma or intraocular hypertension
• Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV
• Subjects who have had a diagnosis of alcohol or substance dependence.

Where it is running

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

Full record on ClinicalTrials.gov

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