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

Phase 1

Terminated

• Conditions: Part 1 - Healthy Volunteers; Part 2 - Patients With Hypertension
• Interventions: Drug: Placebo to LFF269; Drug: LFF269

• Registration Number: NCT02047656
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-01-26
• Study First Submitted QC: 2014-01-26
• Study First Posted: 2014-01-28
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to LFF269 (Part 1)	Placebo to LFF269	Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers
LFF269 (Part 2)	LFF269	LFF269 twice daily (b.i.d) for 5 days in patients with hypertension
LFF269 (Part 1)	LFF269	LFF269 twice daily (b.i.d) for 10 days in healthy volunteers

Primary Outcome Measures

Name	Time	Method
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)	10 days

Secondary Outcome Measures

Name	Time	Method
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
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 (AUCtau)[Part 1- Healthy volunteers]	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 2 - Patients with hypertension]	Day 5
Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)	5 days
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]	Day 1
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Miami, Florida, United States