NCT01366339

Brief Summary

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2003

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, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
7.5 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

2 months

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Peak Plasma Concentration (Cmax) of oral doses of MNTX

    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

    7 days

Secondary Outcomes (3)

  • Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX

    7 days

  • Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX

    7 days

  • Half-life of oral doses of MNTX

    7 days

Study Arms (4)

Arm 1

EXPERIMENTAL

Oral methylnaltrexone

Drug: Oral methylnaltrexone

Arm 2

EXPERIMENTAL

Oral methylnaltrexone

Drug: Oral methylnaltrexone

Arm 3

EXPERIMENTAL

Oral methylnaltrexone

Drug: Oral methylnaltrexone

Arm 4

PLACEBO COMPARATOR

Oral placebo

Drug: Oral placebo

Interventions

Oral methylnaltrexoneDRUG
Arm 1Arm 2Arm 3
Oral placeboDRUG
Arm 4

Eligibility Criteria

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

You may qualify if:

  • Weight between 55 and 85 kg
  • In good health with no evidence of a clinically significant chronic medical condition
  • Non-Smokers.

You may not qualify if:

  • History of asthma, allergic skin rash, significant allergy or other immunologic disorder
  • Known or suspected hypersensitivity to opioids or opioid antagonists
  • History or suspicion of alcohol or drug abuse.

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, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)