| Primary | Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) | | Pharmacokinetic analysis set | Posted | | Median | Full Range | hour | | 1 and 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| | | Title | Denominators | Categories |
|---|
| AHU377 (Sacubitril) on day 1 | | | Title | Measurements |
|---|
| - OG0000.5(0.5 to 1)
- OG0010.5(0.5 to 1.0)
|
| | AHU377 (Sacubitril) on day 5 | | |
| |
| Secondary | 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers | | | Posted | | Mean | Standard Deviation | mmol/day | | 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
|
| Primary | (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) | | Pharmacokinetic analysis set | Posted | | Mean | Standard Deviation | ng/mL | | 1 and 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
|
| Primary | AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) | | Pharmacokinetic analysis set | Posted | | Mean | Standard Deviation | (hr*ng/mL) | | 1 and 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
|
| Primary | T1/2 After Multiple Dose Administration (Day 5) | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 | Pharmacokinetic analysis set | Posted | | Mean | Standard Deviation | (hr) | | 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
|
| Primary | CL/F After Multiple Dose Administration (Day 5) | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 | Pharmacokinetic analysis set | Posted | | Mean | Standard Deviation | (ml/hr) | | 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
|
| Primary | CLr After Multiple Dose Administration (Day 5) | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 | Pharmacokinetic analysis set | Posted | | Mean | Standard Deviation | (ml/hr) | | 5 days | | | | ID | Title | Description |
|---|
| OG000 | Renal Impaired Subjects | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days | | OG001 | Healthy Volunteers | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
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