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

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ClinicalTrials.gov Identifier: NCT01366326
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: Methylnaltrexone bromide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects
Study Start Date : July 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Methylnaltrexone bromide
Drug: Methylnaltrexone bromide
Subcutaneous MNTX



Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of MNTX and its Metabolites [ Time Frame: 7 days ]
    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 :
  1. Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites [ Time Frame: 7 Days ]
    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.

  2. Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites. [ Time Frame: 7 Days ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366326


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

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01366326     History of Changes
Other Study ID Numbers: MNTX 1109
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

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