NCT01367483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

Same day

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX

    5.5 Days

  • Clearance of IV MNTX

    5.5 days

  • Half-life of IV MNTX

    5.5 days

  • Volume of Distribution of IV MNTX

    5.5 days

  • Urinary Clearance of IV MNTX

    5.5 days

Study Arms (1)

Arm1

EXPERIMENTAL

MNTX active treatment

Drug: IV methylnaltrexone (MNTX)

Interventions

IV methylnaltrexone (MNTX)DRUG
Arm1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

methylnaltrexone

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

June 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)