Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

IV methylnaltrexone (MNTX)

Group Type EXPERIMENTAL

methylnaltrexone

Intervention Type DRUG

Arm 2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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methylnaltrexone

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Subjects who were non-smokers
3. Subjects with body weights within range of 70-100 kg (154-220 lbs).

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes