Odiparcil QT Definitive Study

Phase 1TerminatedNCT00437242

GlaxoSmithKline54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibrillation, Atrial Atrial Fibrillation

Interventions

OdiparcilDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion: * Healthy volunteers Exclusion: * Cardiac abnormalities * Hepatic or renal insufficiency * Anti-coagulant medications * Bleeding history

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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