Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.

Key facts

Study ID

NCT00474799

Run by

Javelin Pharmaceuticals

People needed

32

Starts

2007-01-01

Expected to finish

2007-02-01

Last updated by the study team

2008-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult volunteers 18 years of age or older

You may not qualify if…

• History of alcohol, drug addiction, or substance abuse.
• Known to or suspected to be currently abusing alcohol or drugs.
• Allergy or hypersensitivity to shellfish or opioids.
• History of seizures.
• Clinically significant structural or functional abnormalities of the nose and upper airway, obstruction of the nasal passages, or mucosal lesions of the nostrils.
• Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
• Positive for hepatitis B or hepatitis C or HIV antibodies.

Where it is running

• CEDRA Corporation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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