Tolerance and Pharmacokinetics Study of MNTX Tablets

Completed · Phase 1 · Has a placebo group

Conditions studied: Normal Healthy Volunteers

In brief

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Key facts

Study ID

NCT01366339

Run by

Bausch Health Americas, Inc.

People needed

37

Starts

2003-10-01

Expected to finish

2003-12-01

Last updated by the study team

2019-11-27

Who can join

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

You may qualify if…

• Weight between 55 and 85 kg
• In good health with no evidence of a clinically significant chronic medical condition
• Non-Smokers.

You may not qualify if…

• History of asthma, allergic skin rash, significant allergy or other immunologic disorder
• Known or suspected hypersensitivity to opioids or opioid antagonists
• History or suspicion of alcohol or drug abuse.

Where it is running

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

Full record on ClinicalTrials.gov

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