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Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01366378
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.


Condition Intervention Phase
Healthy Adult Subjects
 Drug: methylnaltrexone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX


Secondary Outcome Measures:
  • Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  • Half-life of MNTX prior to and following a multi-dose cimetidine regimen [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  • Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  • Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  • Number of subject with adverse events as measured before, during, and after administration of cimetidine [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the potential effects of cimetidine on safety, and tolerability of MNTX


Enrollment: 18
Study Start Date: January 2007
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
methylnaltrexone (MNTX)
 Drug: methylnaltrexone

  Eligibility

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

Inclusion Criteria:

  1. Healthy males and females between the ages of 18 and 45
  2. Subjects who are non-smokers
  3. Subjects with body weights with range of 154-220 lbs.

Exclusion Criteria:

  1. Females who are pregnant or lactating
  2. Subjects with a history of any clinically significant disease or condition affecting a major organ system
  3. Subjects with ECG abnormalities
  4. Subjects who have tested positive for hepatitis B, hepatitis C or HIV
  5. Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
  6. Subjects with positive urine results for drugs of abuse.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366378

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: NCT01366378     History of Changes
Other Study ID Numbers: MNTX 1304
Study First Received: May 27, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cimetidine
Methylnaltrexone
Naltrexone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
 Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013