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

NCT01367509 | Completed Phase 1

• 1 other identifier: MNTX 1105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax) of MNTX in patients with impaired renal function compared to healthy subjects

  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.

  6 days

Secondary Outcomes (4)

• Peak time of maximum concentration (Tmax) of MNTX in patients with impaired renal function compared to healthy subjects

  6 days

• Area under the plasma concentration (AUC) of MNTX in patients with impaired renal function compared to healthy subjects

  6 days

• Percent of dose excreted in urine of MNTX in patients with impaired renal function compared to healthy subjects

  6 days

• Urinary clearance of MNTX in patients with impaired renal function compared to healthy subjects

  6 days

Study Arms (1)

Arm 1

EXPERIMENTAL

SC Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Interventions

Methylnaltrexone (MNTX) DRUG

Arm 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.
• 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
• Patients with impaired renal function, good general health except for those illnesses associated with CKD.

You may not qualify if:

• Subjects/patients with any conditions possibly affecting drug absorption (eg. Gastrectomy or clinically significant diabetic gastroenteropathy)
• Methadone use
• Consumption of grapefruit or grapefruit juice within seven (7) days prior to administration of study medication.
• Patients requiring hemodialysis.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tage Ramakrishna, MD

  Progenics Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 7, 2011
• Study Start: March 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: June 1, 2005
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

US (1)