Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: MNS075 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Javelin Pharmaceuticals
Summary
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.
Clinical Details
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
Study design: Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
CEDRA Corporation, Austin, Texas 78754, United States
Additional Information
Starting date: January 2007
Ending date: February 2007
Last updated: May 16, 2007
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