This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.
This study will assess the effect of therapeutic and supratherapeutic plasma exposures of CS-3150 on the corrected QT (QTc) interval duration after administration of single oral 10-mg and 40-mg doses of CS-3150 in healthy male and female participants. This study will also determine the safety and tolerability of CS-3150 administration, assess the effect on electrocardiogram (ECG) parameters, detect QT interval (QT)/QTc prolongation with a positive control (moxifloxacin), characterize pharmacokinetics (PK) of CS-3150, and assess exposure-response relationship of CS-3150 on QTc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
55
Single, oral administration; 10-mg or 40-mg dose
Single, oral administration; 400 mg-tablet
Placebo tablets matching moxifloxacin tablets
Worldwide Clinical Trials
San Antonio, Texas, United States
Change in corrected QT (QTc) interval from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
On the electrocardiogram tracing, the estimated difference in least square means will be reported between each CS-3150 dose level and placebo in QTc change from baseline.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Percentage of participants reporting treatment-emergent adverse events (TEAEs) following oral administration of 1 of 4 treatment sequences with CS-3150
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in corrected QT (QTc) interval from baseline following oral administration of 1 of 4 treatment sequences with moxifloxacin
On the electrocardiogram tracing, the estimated difference in least square means will be reported between moxifloxacin and placebo in QTc change from baseline.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in the interval between the P and R waves (PR) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
On the electrocardiogram tracing, the interval between the P and R waves (PR) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QRS wave complex (QRS) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
On the electrocardiogram tracing, QRS wave complex (QRS) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QT interval (QT) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
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Placebo tablets matching CS-3150 tablets
On the electrocardiogram tracing, QT interval (QT) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QTc corrected by Bazett's formula (QTcB) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
On the electrocardiogram tracing, QTc corrected by Bazett's formula (QTcB) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QTc corrected by Fridericia's formula (QTcF) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
On the electrocardiogram tracing, QTc corrected by Fridericia's formula (\[QTcF\]) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in heart rate (HR) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Based on the electrocardiogram tracing, heart rate (HR) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)