Study of Pharmacokinetics, Safety and Tolerability of Int... | NCT01366365

Studies
Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

NCT01366365

Sponsor

Bausch Health Americas, Inc.

Status

Completed

Last Update Posted

Nov 27, 2019Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Healthy Adults

Interventions

methylnaltrexone
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

May 27, 2011

First Submission Date that Met QC Criteria

Jun 2, 2011

First Posted Date

Jun 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2019

Last Update Posted Date

Nov 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	IV methylnaltrexone (MNTX)	Drug: methylnaltrexone
Arm 2	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
methylnaltrexone	Drug		Arm 1
placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tage Ramakrishna, MD	Progenics Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Progenics Pharmaceuticals, Inc.		Tarrytown	New York	10591	United States

Intervention Browse Module

MeSH Terms

ID	Term
C032257	methylnaltrexone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided