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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

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.

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Detailed Description

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Conditions

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Part 1 - Healthy Volunteers Part 2 - Patients With Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo to LFF269 (Part 1)

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

Group Type PLACEBO_COMPARATOR

Placebo to LFF269

Intervention Type DRUG

Placebo LFF269 b.i.d for 10 days in healthy volunteers

LFF269 (Part 1)

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

Group Type EXPERIMENTAL

LFF269

Intervention Type DRUG

LFF269 capsules twice daily (b.i.d)

LFF269 (Part 2)

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

Group Type EXPERIMENTAL

LFF269

Intervention Type DRUG

LFF269 capsules twice daily (b.i.d)

Interventions

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LFF269

LFF269 capsules twice daily (b.i.d)

Intervention Type DRUG

Placebo to LFF269

Placebo LFF269 b.i.d for 10 days in healthy volunteers

Intervention Type DRUG

Other Intervention Names

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LFF269 active placebo

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes