Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-06-30

Brief Summary

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This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.

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Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1

MNTX active treatment

Group Type EXPERIMENTAL

IV methylnaltrexone (MNTX)

Intervention Type DRUG

Interventions

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IV methylnaltrexone (MNTX)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males between 18-45
2. Subject weight between 70 and 90 kg
3. In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion Criteria

1. History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
2. Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
3. History of or predisposition to erratic or abnormal bowel function.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes