Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects

Conditions
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Healthy Adults

Intervention / Treatment
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* Drug: methylnaltrexone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subjects who were non-smokers Subjects with body weights within range of 70-100 kg (154-220 lbs). Exclusion Criteria: Subjects who had previously been exposed to MNTX Subjects with a history of vasovagal episodes or fainting within the past five years Subjects with a history of psychiatric or neurologic disorder Subjects with a history of narrow-angle glaucoma or intraocular hypertension Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV Subjects who have had a diagnosis of alcohol or substance dependence.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>IV methylnaltrexone (MNTX) | Drug: methylnaltrexone<br> <br> |
| Placebo Comparator: Arm 2<br>placebo | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 7 days |