Study Complete
Sponsor ID
20090231

Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults

Sponsor ID
20090231
Clinicaltrials.gov ID
NCT04175808
EUCTIS ID
N/A
EudraCT ID
2018-003157-19

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.

Additional Study Details

Phase
Phase 1
Product
AMG 423
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
70
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in QT interval corrected for heart rate based on the Fridericia correction

Timeframe: Day-1 to Day-6

Secondary Outcome Measures

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

Locations

No locations found.