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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Part 2 - Patients With Hypertension; Part 1 - Healthy Volunteers

Treatments: Drug: LFF269; Drug: Placebo to LFF269

Study type: Interventional

Funder types: Industry

Identifiers

NCT02047656

CLFF269X2105

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 3 patient groups, including a placebo group

Placebo to LFF269 (Part 1)

Placebo Comparator group

Description:

Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers

Treatment:

Drug: Placebo to LFF269

LFF269 (Part 1)

Experimental group

Description:

LFF269 twice daily (b.i.d) for 10 days in healthy volunteers

Treatment:

Drug: LFF269

LFF269 (Part 2)

Experimental group

Description:

LFF269 twice daily (b.i.d) for 5 days in patients with hypertension

Treatment:

Drug: LFF269