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Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01366326
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  Purpose

MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.


Condition Intervention Phase
Healthy Adult Subjects
 Drug: Methylnaltrexone bromide
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of MNTX and its Metabolites [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.


Secondary Outcome Measures:
  • Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.

  • Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites. [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.


Enrollment: 20
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Methylnaltrexone bromide
 Drug: Methylnaltrexone bromide
Subcutaneous MNTX

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Body weight ≥40 kg (88 lb)
  2. In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
  3. Non-smoker
  4. Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).

Exclusion Criteria:

  1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
  2. History of clinically significant allergies
  3. Positive urine screen for drugs
  4. History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
  5. Prior exposure, allergy or known hypersensitivity to methylnaltrexone
  6. Diagnosis of alcohol or substance dependence within the past 12 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366326

Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01366326     History of Changes
Other Study ID Numbers: MNTX 1109
Study First Received: May 27, 2011
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bromides
Methylnaltrexone
Naltrexone
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013