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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367509
• Other study ID #: MNTX 1105
• Status: Completed
• Phase: Phase 1
• Start date: March 2004
• Est. completion date: June 2005

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Methylnaltrexone (MNTX)

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peak time of maximum concentration (Tmax) 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	Area under the plasma concentration (AUC) 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	Percent of dose excreted in urine 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	Urinary clearance 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