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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01366339 |
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Date of registration:
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27/05/2011 |
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Primary sponsor: |
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Public title:
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Tolerance and Pharmacokinetics Study of MNTX Tablets
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Scientific title:
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A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01366339 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Tage Ramakrishna, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Progenics Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Normal Healthy Volunteers
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Intervention(s)
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Drug: Oral methylnaltrexone
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Drug: Oral placebo
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Primary Outcome(s)
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Peak Plasma Concentration (Cmax) of oral doses of MNTX
[Time Frame: 7 days]
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Secondary Outcome(s)
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Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX
[Time Frame: 7 days]
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Half-life of oral doses of MNTX
[Time Frame: 7 days]
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Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX
[Time Frame: 7 days]
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Secondary ID(s)
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MNTX 1201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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