To Evaluate Pharmacokinetics of LFF269 in Healthy Volunte... | NCT02047656

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

NCT02047656

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Apr 1, 2016Estimated

Enrollment

93Actual

Phase

Phase 1

Conditions

Part 1 - Healthy Volunteers
Part 2 - Patients With Hypertension

Interventions

LFF269
Placebo to LFF269

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jan 26, 2014

First Submission Date that Met QC Criteria

Jan 26, 2014

First Posted Date

Jan 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2016

Last Update Posted Date

Apr 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo to LFF269 (Part 1)	Placebo Comparator	Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers	Drug: Placebo to LFF269
LFF269 (Part 1)	Experimental	LFF269 twice daily (b.i.d) for 10 days in healthy volunteers	Drug: LFF269
LFF269 (Part 2)	Experimental	LFF269 twice daily (b.i.d) for 5 days in patients with hypertension	Drug: LFF269

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LFF269	Drug	LFF269 capsules twice daily (b.i.d)	LFF269 (Part 1) LFF269 (Part 2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)		10 days

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers]		Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases