Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367483
• Other study ID #: MNTX 102
• Status: Completed
• Phase: Phase 1
• Start date: June 2005
• Est. completion date: June 2005

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• IV methylnaltrexone (MNTX)

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 days
Secondary	Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 Days
Secondary	Clearance of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 days
Secondary	Half-life of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 days
Secondary	Volume of Distribution of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 days
Secondary	Urinary Clearance of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 days