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LCZ696A

Phase 2

Pharmacokinetics | Small molecule | Nephrology |Novartis AG|Last Updated: Sep 29, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01569828Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal FunctionPHASE2 COMPLETED 12Mar 1, 2009Sep 1, 2009Sep 29, 20153 Germany, Russia +1
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Study Endpoints
Primary Endpoints
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
1 and 5 days
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
1 and 5 days
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
1 and 5 days
T1/2 After Multiple Dose Administration (Day 5)
5 days

Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

CL/F After Multiple Dose Administration (Day 5)
5 days

Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

CLr After Multiple Dose Administration (Day 5)
5 days

Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

Secondary Endpoints
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
5 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Renal Impaired SubjectsEXPERIMENTALonce daily administration of 400 mg LCZ696 for 5 days
Healthy VolunteersEXPERIMENTALonce daily administration of 400 mg LCZ696 for 5 days
Interventions
NameTypeDescription
LCZ696ADRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: \- Exclusion Criteria: \-

Countries:GermanyRussiaSerbia
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