An Open-Label, Phase I, Single Dose Study of the Pharmacokinetics, Mass Balance and Disposition of Intravenously Administered 14C-Methylnaltrexone in Normal, Healthy Volunteers

Bausch Health Americas, Inc.1 site in 1 country6 target enrollmentJune 2005

ConditionsHealthy Male Volunteers

InterventionsIV methylnaltrexone (MNTX)

DrugsIV methylnaltrexone (MNTX)

Overview

Phase: Phase 1
Intervention: IV methylnaltrexone (MNTX)
Conditions: Healthy Male Volunteers
Sponsor: Bausch Health Americas, Inc.
Enrollment: 6
Locations: 1
Primary Endpoint: Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

June 2005

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Bausch Health Americas, Inc.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Arm1

MNTX active treatment

Intervention: IV methylnaltrexone (MNTX)

Outcomes

Primary Outcomes

Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX

Time Frame: 5.5 days

To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

Secondary Outcomes

Urinary Clearance of IV MNTX(5.5 days)
Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX(5.5 Days)
Clearance of IV MNTX(5.5 days)
Half-life of IV MNTX(5.5 days)
Volume of Distribution of IV MNTX(5.5 days)