NCT00474799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

Enrollment Period

1 month

First QC Date

May 15, 2007

Last Update Submit

January 11, 2008

Conditions

Healthy

Outcome Measures

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.

    Multiple

Study Arms (2)

A

EXPERIMENTAL

MNS075 7.5mg q1h

Drug: MNS075

B

EXPERIMENTAL

MNS075 15mg q3h

Drug: MNS075

Interventions

MNS075DRUG

MNS075 7.5mg q1h MNS075 15mg q3h

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult volunteers 18 years of age or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEDRA Corporation

Austin, Texas, 78754, United States

Location

Study Officials

  • Javelin Pharmaceuticals

    Javelin Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 17, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

US(1)