Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367509
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.


Condition Intervention Phase
Renal Impairment
Drug: Methylnaltrexone (MNTX)
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 to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of MNTX in patients with impaired renal function compared to healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.


Secondary Outcome Measures:
  • Peak time of maximum concentration (Tmax) of MNTX in patients with impaired renal function compared to healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.

  • Area under the plasma concentration (AUC) of MNTX in patients with impaired renal function compared to healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.

  • Percent of dose excreted in urine of MNTX in patients with impaired renal function compared to healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.

  • Urinary clearance of MNTX in patients with impaired renal function compared to healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.


Enrollment: 32
Study Start Date: March 2004
Study Completion Date: June 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
SC Methylnaltrexone (MNTX)
Drug: Methylnaltrexone (MNTX)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Body weight >100 lbs. (> 45 kg), and body mass index (BMI) between 18-38 kg/m2, inclusive (BMI 18-30 for the matched reference group)
  2. For patients/subjects requiring pharmacotherapy, a stable drug regimen, defined as not having started a new drug or changed dosage within three (3) days or five (5) half-lives (whichever was longer) prior to administration of MNTX concomitant medication must either have conformed to the list of approved drugs and dosage or have been approved by the sponsor.
  3. Patients with normal renal function, demographically comparable to the patients with impaired renal function weights and ages were within the range of chronic kidney disease (CKD) group and the average for the matched reference group was within 10 years and 10 kg of the average for the CKD
  4. Patients with impaired renal function, good general health except for those illnesses associated with CKD.

Exclusion Criteria:

  1. Subjects/patients with any conditions possibly affecting drug absorption (eg. Gastrectomy or clinically significant diabetic gastroenteropathy)
  2. Methadone use
  3. Consumption of grapefruit or grapefruit juice within seven (7) days prior to administration of study medication.
  4. Patients requiring hemodialysis.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01367509

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
ClinicalTrials.gov Identifier: NCT01367509     History of Changes
Other Study ID Numbers: MNTX 1105
Study First Received: May 27, 2011
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Methylnaltrexone
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014