Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

Completed · Phase 1

Conditions studied: Healthy Male Volunteers

In brief

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.

Key facts

Study ID

NCT01367483

Run by

Bausch Health Americas, Inc.

People needed

6

Starts

2005-06-01

Expected to finish

2005-06-01

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Progenics Pharmaceuticals, Inc. — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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