NCT01366365

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

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

October 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Half-life of MNTX

    7 days

  • Volume of distribution of MNTX

    7 days

  • Area under the plasma concentration (AUC) of MNTX

    7 days

  • Number of Subjects with Adverse Events

    7 days

Study Arms (2)

Arm 1

EXPERIMENTAL

IV methylnaltrexone (MNTX)

Drug: methylnaltrexone

Arm 2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

methylnaltrexoneDRUG
Arm 1
placeboDRUG
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 6, 2011

Study Start

October 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)