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TerminatedNCT02047656Updated Apr 1, 2016

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

A Phase 1 interventional study of LFF269 and Placebo to LFF269 in Part 1 - Healthy Volunteers and Part 2 - Patients With Hypertension, sponsored by Novartis Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-01.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Healthy volunteers, hypertension
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 93 is close to the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
93 participants (actual)

Study arms

  • Placebo comparator
    Placebo to LFF269 (Part 1)

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

    Drug: Placebo to LFF269

  • Experimental
    LFF269 (Part 1)

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

    Drug: LFF269

  • Experimental
    LFF269 (Part 2)

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

    Drug: LFF269

Interventions

  • DrugLFF269

    LFF269 capsules twice daily (b.i.d)

    Also known as: LFF269 active

  • DrugPlacebo to LFF269

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

    Also known as: placebo

06

What researchers measure

Primary outcomes

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

    Time frame: 10 days

Secondary outcomes

  1. 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

  2. Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]

    Time frame: Day 1

  3. 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

  4. Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension]

    Time frame: Day 1

  5. 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

  6. 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

  7. Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension]

    Time frame: Up to Day 5

  8. Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers]

    Time frame: Up to Day 10

  9. Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)

    Time frame: 5 days

07

Study locations

1 site
  • Novartis Investigative Site
    Miami, Florida 33126, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2014
First posted
Jan 28, 2014
Start
Aug 2013
Primary completionActual
Aug 2014
CompletionActual
Aug 2014
Last update
Apr 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02047656
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 28, 2014
Start date
Aug 2013
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Apr 1, 2016

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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