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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

MNS075 7.5mg q1h

Group Type EXPERIMENTAL

MNS075

Intervention Type DRUG

MNS075 7.5mg q1h MNS075 15mg q3h

B

MNS075 15mg q3h

Group Type EXPERIMENTAL

MNS075

Intervention Type DRUG

MNS075 7.5mg q1h MNS075 15mg q3h

Interventions

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MNS075

MNS075 7.5mg q1h MNS075 15mg q3h

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes