Odiparcil QT Definitive Study

A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437242

Enrollment

Registered

2007-02-19

Start date

2006-10-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Fibrillation, Atrial

Keywords

interval,, atrial fibrillation, QT,, odiparcil,

Brief summary

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

Interventions

DRUGOdiparcil

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026