To Evaluate Pharmacokinetics of LFF269 in Healthy Volunteers and Patients With Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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A Two Part Study Including a Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LFF269 After b.i.d Dosing in Healthy Volunteers and an Open Label, Multiple Dose Pharmacokinetics Study in Hypertension Subjects

Conditions
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Part 1 - Healthy Volunteers, Part 2 - Patients With Hypertension

Intervention / Treatment
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* Drug: LFF269
* Drug: Placebo to LFF269


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part 1 - Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Part 2 Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive. Patients with mild-to-moderate uncomplicated essential hypertension Exclusion Criteria: Part 1 History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes. A history of clinically significant ECG abnormalities. Known history or current clinically significant arrhythmias. History of hypertension, adrenal or endocrine disease. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. Smokers (use of tobacco products in the previous 3 months). History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. A positive Hepatitis B surface antigen or Hepatitis C test result. Part 2 Pregnant or nursing (lactating) women. Women of child-bearing potential. Known history or evidence of a secondary form of hypertension Type 1 or type 2 diabetes mellitus. History of heart diseases A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. Other protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo to LFF269 (Part 1)<br>Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers | Drug: Placebo to LFF269<br>* Placebo LFF269 b.i.d for 10 days in healthy volunteers<br>* Other names: placebo;|
| Experimental: LFF269 (Part 1)<br>LFF269 twice daily (b.i.d) for 10 days in healthy volunteers | Drug: LFF269<br>* LFF269 capsules twice daily (b.i.d)<br>* Other names: LFF269 active;|
| Experimental: LFF269 (Part 2)<br>LFF269 twice daily (b.i.d) for 5 days in patients with hypertension | Drug: LFF269<br>* LFF269 capsules twice daily (b.i.d)<br>* Other names: LFF269 active;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1) |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers] |  | Day 1 | 
| Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers] |  | 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] |  | Day 1 | 
| Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension] |  | 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] |  | 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] |  | Day 5 | 
| Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension] |  | Up to Day 5 | 
| Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers] |  | Up to Day 10 | 
| Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension) |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, hypertension