Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: IV methylnaltrexone (MNTX)

• Registration Number: NCT01367483
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm1	IV methylnaltrexone (MNTX)	MNTX active treatment

Primary Outcome Measures

Name	Time	Method
Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX	5.5 days	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

Secondary Outcome Measures

Name	Time	Method
Urinary Clearance of IV MNTX	5.5 days	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX	5.5 Days	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
Clearance of IV MNTX	5.5 days	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
Half-life of IV MNTX	5.5 days	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
Volume of Distribution of IV MNTX	5.5 days	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States