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

May 27, 2011
July 17, 2011
October 2003
December 2003   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01366339 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Tolerance and Pharmacokinetics Study of MNTX Tablets
A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Normal Healthy Volunteers
  • Drug: Oral methylnaltrexone
  • Drug: Oral placebo
  • Experimental: Arm 1
    Oral methylnaltrexone
    Intervention: Drug: Oral methylnaltrexone
  • Experimental: Arm 2
    Oral methylnaltrexone
    Intervention: Drug: Oral methylnaltrexone
  • Experimental: Arm 3
    Oral methylnaltrexone
    Intervention: Drug: Oral methylnaltrexone
  • Placebo Comparator: Arm 4
    Oral placebo
    Intervention: Drug: Oral placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2003
December 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01366339
MNTX 1201
No
Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
Not Provided
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP