Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: MNS075
- Registration Number
- NCT00474799
- Lead Sponsor
- Javelin Pharmaceuticals
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A MNS075 MNS075 7.5mg q1h B MNS075 MNS075 15mg q3h
- Primary Outcome Measures
Name Time Method 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. Multiple
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CEDRA Corporation
🇺🇸Austin, Texas, United States