NCT01363323

Brief Summary

This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
546

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2004

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

November 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Effects of MNTX on QTcI duration

    The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers.

    3 days

Study Arms (5)

Arm 1

EXPERIMENTAL
Drug: Methylnaltrexone (MNTX)

Arm 2

EXPERIMENTAL
Drug: Methylnaltrexone (MNTX)

Arm 3

EXPERIMENTAL
Drug: Methylnaltrexone (MNTX)

Arm 4

PLACEBO COMPARATOR
Drug: Placebo

Arm 5

ACTIVE COMPARATOR
Drug: Moxifloxacin

Interventions

Methylnaltrexone (MNTX)DRUG

Dose 1

Arm 1
PlaceboDRUG
Arm 4
MoxifloxacinDRUG
Arm 5

Eligibility Criteria

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

You may qualify if:

  • Healthy and free of acute active illnesses
  • Males and females between the ages of 18 and 45 years, inclusive
  • Body mass index between 18-30, inclusive, and weight between 50-110 kgs
  • ECG within normal limits (including PR \<220, QRS \<110, and QTc \<450 ms.)

You may not qualify if:

  • Previous MNTX exposure
  • Currently pregnant or nursing
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
  • Consumption of alcoholic beverages within 7 days prior to study confinement
  • Any evidence of congenital or familial long-QT syndrome
  • History of drug abuse of positive findings on urine drug screen
  • Known allergy or hypersensitivity to MNTX or its excipients, moxifloxacin, opioids, or related drugs or a history or relevant adverse drug reactions of any origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

methylnaltrexoneMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 1, 2011

Study Start

November 1, 2004

Primary Completion

January 1, 2005

Study Completion

February 1, 2005

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations

US(1)