Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Bausch Health Americas, Inc.28 enrolled

Overview

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Adults

Interventions

methylnaltrexoneDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older. 2. Subjects who were non-smokers 3. Subjects with body weights within range of 70-100 kg (154-220 lbs). Exclusion Criteria: 1. Subjects who had previously been exposed to MNTX 2. Subjects with a history of vasovagal episodes or fainting within the past five years 3. Subjects with a history of psychiatric or neurologic disorder 4. Subjects with a history of narrow-angle glaucoma or intraocular hypertension 5. Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV 6. Subjects who have had a diagnosis of alcohol or substance dependence.

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Clearance of MNTX

Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Time frame: 7 days

Secondary Outcomes

Half-life of MNTX

Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Time frame: 7 days

Volume of distribution of MNTX

Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Time frame: 7 days

Area under the plasma concentration (AUC) of MNTX

Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Time frame: 7 days

Number of Subjects with Adverse Events

Safety and tolerability of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Time frame: 7 days

Data from ClinicalTrials.gov

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