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

Primary Purpose

Part 1 - Healthy Volunteers, Part 2 - Patients With Hypertension

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LFF269
Placebo to LFF269
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Part 1 - Healthy Volunteers focused on measuring Healthy volunteers, hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo to LFF269 (Part 1)

LFF269 (Part 1)

LFF269 (Part 2)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)

Secondary Outcome Measures

Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers]
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension]
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension]
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]
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]
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension]
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers]
Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)

Full Information

First Posted
January 26, 2014
Last Updated
March 30, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02047656
Brief Title
To Evaluate Pharmacokinetics of LFF269 in Healthy Volunteers and Patients With Hypertension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Part 1 - Healthy Volunteers, Part 2 - Patients With Hypertension
Keywords
Healthy volunteers, hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo to LFF269 (Part 1)
Arm Type
Placebo Comparator
Arm Description
Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers
Arm Title
LFF269 (Part 1)
Arm Type
Experimental
Arm Description
LFF269 twice daily (b.i.d) for 10 days in healthy volunteers
Arm Title
LFF269 (Part 2)
Arm Type
Experimental
Arm Description
LFF269 twice daily (b.i.d) for 5 days in patients with hypertension
Intervention Type
Drug
Intervention Name(s)
LFF269
Other Intervention Name(s)
LFF269 active
Intervention Description
LFF269 capsules twice daily (b.i.d)
Intervention Type
Drug
Intervention Name(s)
Placebo to LFF269
Other Intervention Name(s)
placebo
Intervention Description
Placebo LFF269 b.i.d for 10 days in healthy volunteers
Primary Outcome Measure Information:
Title
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers]
Time Frame
Day 1
Title
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]
Time Frame
Day 1
Title
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension]
Time Frame
Day 1
Title
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension]
Time Frame
Day 1
Title
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]
Time Frame
Day 10
Title
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]
Time Frame
Day 5
Title
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension]
Time Frame
Up to Day 5
Title
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers]
Time Frame
Up to Day 10
Title
Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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