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Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01366365
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  Purpose

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.


Condition Intervention Phase
Healthy Adults
 Drug: methylnaltrexone
Drug: 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 Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Clearance of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses


Secondary Outcome Measures:
  • Half-life of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

  • Volume of distribution of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

  • Area under the plasma concentration (AUC) of MNTX [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

  • Number of Subjects with Adverse Events [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Safety and tolerability of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses


Enrollment: 28
Study Start Date: October 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
IV methylnaltrexone (MNTX)
 Drug: methylnaltrexone
Placebo Comparator: Arm 2
placebo
 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older.
  2. Subjects who were non-smokers
  3. Subjects with body weights within range of 70-100 kg (154-220 lbs).

Exclusion Criteria:

  1. Subjects who had previously been exposed to MNTX
  2. Subjects with a history of vasovagal episodes or fainting within the past five years
  3. Subjects with a history of psychiatric or neurologic disorder
  4. Subjects with a history of narrow-angle glaucoma or intraocular hypertension
  5. Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV
  6. Subjects who have had a diagnosis of alcohol or substance dependence.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366365

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: NCT01366365     History of Changes
Other Study ID Numbers: MNTX 1303
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 May 16, 2013