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

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00474799

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: MNS075	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	An Open Label, Randomized, Single Center, Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) in Opioid naïve, Healthy Adult Volunteers

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

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. [ Time Frame: Multiple ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	January 2007
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A MNS075 7.5mg q1h	Drug: MNS075 MNS075 7.5mg q1h MNS075 15mg q3h
Experimental: B MNS075 15mg q3h	Drug: MNS075 MNS075 7.5mg q1h MNS075 15mg q3h

Detailed Description:

This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult volunteers 18 years of age or older

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474799

Locations

United States, Texas
CEDRA Corporation
Austin, Texas, United States, 78754

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Study Director:

Javelin Pharmaceuticals

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00474799 History of Changes
Other Study ID Numbers:	MOR-PK-006
Study First Received:	May 15, 2007
Last Updated:	January 11, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012