Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults
Study Details
The primary objective of this study is to assess the effect of a single therapeutic (50 mg) oral dose of omecamtiv mecarbil (OM) on the QT interval / QT interval corrected for heart rate (QTc), relative to placebo, in healthy adults.
The QT interval is the section on an electrocardiogram (ECG) that represents the time it takes for the electrical system to fire an impulse through the ventricles and then recharge, or the time it takes for the heart muscle to contract and then recover.
Protocol Summary
Change from baseline in QT interval corrected for heart rate based on the Fridericia correction
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited to maximum serum concentration (Cmax)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited to time to maximum plasma concentration (Tmax)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited to if feasible, half-life (t1/2)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited apparent volume of distribution (VZ/F)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited apparent total plasma clearance (CL/F)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited AUC from time 0 to infinity (AUCinf)
Timeframe: Day-1 to Day-6
PK parameters for Omecamtiv mecarbil following oral administration included but not limited the percentage of AUCinf due to extrapolation (%AUCextrap)
Timeframe: Day-1 to Day-6
Changes in T-wave morphology
Timeframe: Day-1 to Day-6
Changes in U-wave presence
Timeframe: Day-1 to Day-6
Number of Subjects with Changes in laboratory safety tests
Timeframe: Day-1 to Day-6
Number of Subjects with Changes in Blood pressure
Timeframe: Day-1 to Day-6
Number of Subjects with Changes in ECGs parameters
Timeframe: Day-1 to Day-6
Subject incidence of treatment-emergent adverse events (TEAEs)
Timeframe: Day-1 to Day-6
Number of Subjects with Changes in pulse rate
Timeframe: Day-1 to Day-6
Number of Subjects with Changes in body temperature
Timeframe: Day-1 to Day-6