Tolerance and Pharmacokinetics Study of MNTX Tablets

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01366339
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.


Condition Intervention Phase
Normal Healthy Volunteers
Drug: Oral methylnaltrexone
Drug: Oral placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of oral doses of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers


Secondary Outcome Measures:
  • Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

  • Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

  • Half-life of oral doses of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers


Enrollment: 37
Study Start Date: October 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Oral methylnaltrexone
Drug: Oral methylnaltrexone
Experimental: Arm 2
Oral methylnaltrexone
Drug: Oral methylnaltrexone
Experimental: Arm 3
Oral methylnaltrexone
Drug: Oral methylnaltrexone
Placebo Comparator: Arm 4
Oral placebo
Drug: Oral placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Weight between 55 and 85 kg
  2. In good health with no evidence of a clinically significant chronic medical condition
  3. Non-Smokers.

Exclusion Criteria:

  1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder
  2. Known or suspected hypersensitivity to opioids or opioid antagonists
  3. History or suspicion of alcohol or drug abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366339

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: NCT01366339     History of Changes
Other Study ID Numbers: MNTX 1201
Study First Received: May 27, 2011
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014