Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: methylnaltrexone; Drug: placebo

• Registration Number: NCT01366365
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	methylnaltrexone	IV methylnaltrexone (MNTX)
Arm 2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Clearance of MNTX	7 days	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

Secondary Outcome Measures

Name	Time	Method
Half-life of MNTX	7 days	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
Volume of distribution of MNTX	7 days	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
Area under the plasma concentration (AUC) of MNTX	7 days	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
Number of Subjects with Adverse Events	7 days	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

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States