NCT00434395

Brief Summary

The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2007

Typical duration for phase_1 healthy

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

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

First QC Date

February 9, 2007

Last Update Submit

November 21, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Cardiac repolarization will be assessed by the QTc interval in healthy subjects.

Interventions

MOA-728DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy subjects men or women aged 18-50

You may not qualify if:

  • Any significant clinically important disease
  • Family history of long QT syndrome and/or sudden cardiac death
  • Allergy to moxifloxacin or the quinolone class of antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85044, United States

Location

Study Officials

  • Jeff Cohn

    Bausch Health Americas, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

March 1, 2007

Study Completion

October 1, 2007

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

US(1)