| Primary | Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System | AFB is defined as the percent of time spent in atrial fibrillation (AF). AFB will be assessed by use of long term non- invasive beat-to-beat monitoring with the SEEQ MCT system. This technology consists of a low-profile adhesive patch that has been approved for continuous use for up to 30 days. The patch is able to continuously record electrocardiographic signals and, in conjunction with a wirelessly connected portable cellular communications device, transmit these signals for real-time analysis, including atrial and ventricular arrhythmias and AFB. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 to Day 29 | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | | OG003 | Placebo | Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days. |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. | All treated participants included all the participants who have received at least one dose of study treatment. | Posted | | Number | | Participants | | Up to Day 50 | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg |
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| Secondary | Maximum Observed Concentarion (Cmax) of BMS-919373 | Cmax is defined as the maximum observed concentration of BMS-919373. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 1 and Day 22: Predose 1, 2, and 4 hours postdose | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | | OG003 | Placebo |
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| Secondary | Trough Observed Concentration (Cmin) of BMS-919373 | Ctrough is defined as the minimum estimated plasma concentration at steady state. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | |
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| Secondary | Oral Clearance (CL/F) of BMS-919373 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. |
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| Secondary | Central Volume of Distribution (Vc/F) of BMS-919373 | Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Vc/F is a hypothetical volume into which a drug initially distributes upon administration. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. |
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| Secondary | Absorption Rate Constant (Ka) of BMS-919373 | Ka is the absorption rate constant. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | | OG003 |
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| Secondary | Average Concentration (Cavg) of BMS-919373 at Steady State | Cavg is defines as the average concentration at steady state. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | |
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| Secondary | Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373 | AUC is defined as the area under the concentration-time curve at steady state. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | |
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| Secondary | Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic) | The TTFR is defined as the time to the first MCT-recorded AF episode after the first loading dose on Day 1. MCT will provide both "System-triggered" and "Patient-triggered" results and report them separately. "System-triggered" results will include both symptomatic and asymptomatic findings, while "Patient-triggered" results will be the symptomatic ones triggered to report by patients. The analysis will be done both for "System-triggered" and for "Patient-triggered" results. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 to Day 29 | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | |
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| Secondary | Total Number of Atrial Fibrillation Episodes | The total number AF episodes were derived from AF episode histogram data over the monitoring period. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 to Day 29 | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | | OG003 | Placebo |
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| Secondary | Average Duration of Atrial Fibrillation Per Episode | The average duration of AF per episode was calculated from the total time a participant in AF and the total number of AF episodes over the monitoring period. | Data was not collected for any participants due to termination of the study | Posted | | | | | | Day 8 to Day 29 | | | | ID | Title | Description |
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| OG000 | BMS-919373 3/2 mg | Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. | | OG001 | BMS-919373 8/5 mg | Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. | | OG002 | BMS-919373 20/12 mg | Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. | | OG003 |
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