Study in healthy subjects
Conditions
Interventions
Trade Name: Entresto
Product Name: Sacubitril, Valsartan
Product Code: LCZ696
Pharmaceutical Form: Tablet
INN or Proposed INN: SACUBITRIL VALSARTAN
CAS Number: 936623-90-4
Current Sponsor code: LCZ696
Sponsors
Novartis Pharmaceuticals Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female subjects of non-child bearing potential, age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use of investigational drugs within 30 days or 5 half-lives of enrollment, whichever is longer. History of symptomatic orthostatic hypotension or syncope or clinically significant ECG abnormalities. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examine bioavailability of 200 mg minitablets to 200 mg FMI tablets with and without food;Secondary Objective: Measure number of patients with adverse events;Primary end point(s): Pharmacokinetics of LCZ696 ;Timepoint(s) of evaluation of this end point: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of patients with adverse events ;Timepoint(s) of evaluation of this end point: Day 26 | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed