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Completed

NCT Number: NCT00474799

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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CEDRA Corporation

Austin, Texas, 78754, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MNS075

Drug

MNS075 7.5mg q1h MNS075 15mg q3h

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 17, 2007
Registry last updated
Jan 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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