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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000983-27 | EudraCT Number |
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This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: mild hepatic impairment | Experimental | LCZ696 200 mg, given as a single oral dose |
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| Group 2: moderate hepatic impairment | Experimental | LCZ696 200 mg, given as a single oral dose |
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| Group 3: healthy volunteers | Experimental | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer will match in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in groups 1 and 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan) | Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing | From pre-dose on Day 1 until 96h post-dose (Day 5) |
| Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan) | Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing | From pre-dose on Day 1 until 96h post-dose (Day 5) |
| Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan) | Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing | From pre-dose on Day 1 until 96h post-dose (Day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events and Death | Adverse events, serious adverse events and death were monitored from screening to end of study | From the screening visit until Day 5 |
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Inclusion Criteria:
All subjects:
Hepatic impairment subjects:
Exclusion Criteria:
All subjects:
Hepatic impairment subjects:
Healthy subjects:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Grünstadt | D-67269 | Germany |
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Participants received the study treatment according to the population subset that was defined based on the severity of hepatic impairment and healthy volunteers: Group 1, subjects with mild hepatic impairment; Group 2, subjects with moderate hepatic impairment; Groups 3 and 4, healthy volunteers matching to Groups 1 and 2, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Mild Hepatic Impairment (HI) | LCZ696 200 mg, given as a single oral dose |
| FG001 | Participants With Moderate Hepatic Impairment (HI) | LCZ696 200 mg, given as a single oral dose |
| FG002 | Healthy Volunteers (Mild HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1 |
| FG003 | Healthy Volunteers (Moderate HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Mild Hepatic Impairment (HI) | LCZ696 200 mg, given as a single oral dose |
| BG001 | Participants With Moderate Hepatic Impairment (HI) | LCZ696 200 mg, given as a single oral dose |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan) | Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing | PK analysis set: The PK analysis set included all subjects with at least one available, valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug, and experienced no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng*hr/mL | From pre-dose on Day 1 until 96h post-dose (Day 5) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Hepatic Impaired Patients | Moderate hepatic impaired patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| BG002 | Healthy Volunteers (Mild HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1 |
| BG003 | Healthy Volunteers (Moderate HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2 |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Participants With Moderate Hepatic Impairment (HI) |
LCZ696 200 mg, given as a single oral dose |
| OG002 | Healthy Volunteers (Mild HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1 |
| OG003 | Healthy Volunteers (Moderate HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2 |
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan) | Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing | PK analysis set | Posted | Mean | Standard Deviation | ng*hr/mL | From pre-dose on Day 1 until 96h post-dose (Day 5) |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan) | Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing | PK analysis set | Posted | Mean | Standard Deviation | ng/mL | From pre-dose on Day 1 until 96h post-dose (Day 5) |
|
|
|
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Death | Adverse events, serious adverse events and death were monitored from screening to end of study | Safety set: The safety set includes all participants who received study treatment. | Posted | Number | Participants | From the screening visit until Day 5 |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Healthy Volunteers (Mild HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1 | 0 | 8 | 0 | 8 |
| EG002 | Healthy Volunteers (Moderate HI Matched) | LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2 | 0 | 8 | 0 | 8 |
| EG003 | Participants With Mild Hepatic Impairment (HI) | LCZ696 200 mg, given as a single oral dose | 0 | 8 | 0 | 8 |
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA | Systematic Assessment |
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| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| LBQ657 |
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| Valsartan |
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| LBQ657 |
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| Valsartan |
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| Serious adverse events |
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| Deaths |
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