Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01366365

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

27.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Drug: methylnaltrexone Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 IV methylnaltrexone (MNTX)	Drug: methylnaltrexone
Placebo Comparator: Arm 2 placebo	Drug: placebo

Arm

Intervention/Treatment

Experimental: Arm 1

IV methylnaltrexone (MNTX)

Drug: methylnaltrexone

Placebo Comparator: Arm 2

placebo

Drug: placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01366365

Other Study ID Numbers:

MNTX 1303

First Posted:

Jun 6, 2011

Last Update Posted:

Nov 27, 2019

Last Verified:

Nov 1, 2019

Additional relevant MeSH terms:

Methylnaltrexone

Study Results

No Results Posted as of Nov 27, 2019