To Evaluate Pharmacokinetics of LFF269 in Healthy Volunteers and Patients With Hypertension
Status: | Terminated |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | August 2013 |
End Date: | August 2014 |
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
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.
studies by providing additional information about the compounds safety, tolerability,
pharmacokinetic and pharmacodynamic profiles.
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
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