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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01367509
Other study ID # MNTX 1105
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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