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

NCT02047656 | Terminated Phase 1

• 1 other identifier: CLFF269X2105
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Healthy volunteers, hypertension

Outcome Measures

Primary Outcomes (1)

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

  10 days

Secondary Outcomes (9)

• 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]

  Day 1

• Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension]

  Day 1

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

  Day 1

• 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]

  Day 10

Study Arms (3)

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

LFF269 DRUG

LFF269 capsules twice daily (b.i.d)

Also known as: LFF269 active

LFF269 (Part 1); LFF269 (Part 2)

Placebo to LFF269 DRUG

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

Also known as: placebo

Placebo to LFF269 (Part 1)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 28, 2014
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

US (1)