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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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