Tolerance and Pharmacokinetics Study of MNTX Tablets

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2003-12-31

Brief Summary

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This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

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Detailed Description

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Conditions

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Normal Healthy Volunteers

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

Oral methylnaltrexone

Group Type EXPERIMENTAL

Oral methylnaltrexone

Intervention Type DRUG

Arm 2

Oral methylnaltrexone

Group Type EXPERIMENTAL

Oral methylnaltrexone

Intervention Type DRUG

Arm 3

Oral methylnaltrexone

Group Type EXPERIMENTAL

Oral methylnaltrexone

Intervention Type DRUG

Arm 4

Oral placebo

Group Type PLACEBO_COMPARATOR

Oral placebo

Intervention Type DRUG

Interventions

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Oral methylnaltrexone

Intervention Type DRUG

Oral placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Weight between 55 and 85 kg
2. In good health with no evidence of a clinically significant chronic medical condition
3. Non-Smokers.

Exclusion Criteria

1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder
2. Known or suspected hypersensitivity to opioids or opioid antagonists
3. History or suspicion of alcohol or drug abuse.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes