This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
93
LFF269 capsules twice daily (b.i.d)
Placebo LFF269 b.i.d for 10 days in healthy volunteers
Novartis Investigative Site
Miami, Florida, United States
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)
Time frame: 10 days
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers]
Time frame: Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension]
Time frame: Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension]
Time frame: Day 1
Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 1- Healthy volunteers]
Time frame: Day 10
Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 2 - Patients with hypertension]
Time frame: Day 5
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension]
Time frame: Up to Day 5
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers]
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Time frame: Up to Day 10
Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)
Time frame: 5 days