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

NCT01367509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-11-27

No results posted yet for this study

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

Interventions

DRUG

Methylnaltrexone (MNTX)

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Tage Ramakrishna, MD · Progenics Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2005-01-31
Completion
2005-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367509 on ClinicalTrials.gov