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

Javelin Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: MNS075

Study type

Interventional

Funder types

Industry

Identifiers

NCT00474799

MOR-PK-006

Details and patient eligibility

About

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.

Full 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).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.