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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Methylnaltrexone (MNTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367509

MNTX 1105

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Arm 1

Experimental group

Description:

SC Methylnaltrexone (MNTX)

Treatment:

Drug: Methylnaltrexone (MNTX)