Study of the Pharmacokinetics of Intravenous Administered... | NCT01367483

Studies
Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

NCT01367483

Sponsor

Bausch Health Americas, Inc.

Status

Completed

Last Update Posted

Nov 27, 2019Actual

Enrollment

6Estimated

Phase

Phase 1

Conditions

Healthy Male Volunteers

Interventions

IV methylnaltrexone (MNTX)

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

Jun 2005

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

May 27, 2011

First Submission Date that Met QC Criteria

Jun 3, 2011

First Posted Date

Jun 7, 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 is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.

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

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm1	Experimental	MNTX active treatment	Drug: IV methylnaltrexone (MNTX)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV methylnaltrexone (MNTX)	Drug		Arm1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 days

Secondary Outcomes

Measure	Description	Time Frame
Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX	To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.	5.5 Days
Clearance of IV MNTX

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males between 18-45
Subject weight between 70 and 90 kg
In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion Criteria:

History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
History of or predisposition to erratic or abnormal bowel function.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

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