NCT00437242

Brief Summary

This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
Last Updated

June 4, 2012

Status Verified

March 1, 2011

First QC Date

February 16, 2007

Last Update Submit

May 31, 2012

Conditions

Fibrillation, AtrialAtrial Fibrillation

Keywords

interval,atrial fibrillationQT,odiparcil,

Outcome Measures

Primary Outcomes (1)

  • demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours

Secondary Outcomes (1)

  • Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6

Interventions

OdiparcilDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Cardiac abnormalities
  • Hepatic or renal insufficiency
  • Anti-coagulant medications
  • Bleeding history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

odiparcil

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

October 1, 2006

Last Updated

June 4, 2012

Record last verified: 2011-03

Locations

US(1)