Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-08-31

Brief Summary

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This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.

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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

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

SC Methylnaltrexone (MNTX)

Intervention Type DRUG

Arm 2

Group Type EXPERIMENTAL

IV Methylnaltrexone (MNTX)

Intervention Type DRUG

Arm 3

Group Type ACTIVE_COMPARATOR

Oral Paroxetine

Intervention Type DRUG

Arm 4

Group Type PLACEBO_COMPARATOR

SC Placebo

Intervention Type DRUG

Interventions

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SC Methylnaltrexone (MNTX)

Intervention Type DRUG

IV Methylnaltrexone (MNTX)

Intervention Type DRUG

Oral Paroxetine

Intervention Type DRUG

SC Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males between the ages of 18 and 55
2. Non-Smokers
3. Body weight range form 154-220 lbs
4. No history of clinically significant metabolic disorders.

Exclusion Criteria

1. Any history of low CYP450 2D6 activity
2. History of alcohol abuse or recreational drugs
3. History of any clinically significant disease or condition affecting a major organ system
4. Donation or loss of blood, 60 days proceeding to screening visit.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes