Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01363323
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011

May 27, 2011
July 17, 2011
November 2004
January 2005   (final data collection date for primary outcome measure)
Effects of MNTX on QTcI duration [ Time Frame: 3 days ] [ Designated as safety issue: No ]
The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers.
Same as current
Complete list of historical versions of study NCT01363323 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers

This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Methylnaltrexone (MNTX)
    Dose 1
  • Drug: Methylnaltrexone (MNTX)
    Dose 2
  • Drug: Methylnaltrexone (MNTX)
    Dose 3
  • Drug: Placebo
  • Drug: Moxifloxacin
  • Experimental: Arm 1
    Intervention: Drug: Methylnaltrexone (MNTX)
  • Experimental: Arm 2
    Intervention: Drug: Methylnaltrexone (MNTX)
  • Experimental: Arm 3
    Intervention: Drug: Methylnaltrexone (MNTX)
  • Placebo Comparator: Arm 4
    Intervention: Drug: Placebo
  • Active Comparator: Arm 5
    Intervention: Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
546
February 2005
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy and free of acute active illnesses
  2. Males and females between the ages of 18 and 45 years, inclusive
  3. Body mass index between 18-30, inclusive, and weight between 50-110 kgs
  4. ECG within normal limits (including PR <220, QRS <110, and QTc <450 ms.)

Exclusion Criteria:

  1. Previous MNTX exposure
  2. Currently pregnant or nursing
  3. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
  4. Consumption of alcoholic beverages within 7 days prior to study confinement
  5. Any evidence of congenital or familial long-QT syndrome
  6. History of drug abuse of positive findings on urine drug screen
  7. Known allergy or hypersensitivity to MNTX or its excipients, moxifloxacin, opioids, or related drugs or a history or relevant adverse drug reactions of any origin.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01363323
MNTX 1106
No
Tage Ramakrishna, M.D., 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