A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

NCT01621633 | Completed Phase 2 Results

• 2 other identifiers: CLCZ696B22032012-000983-27
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects

Conditions

Hepatic Impairment

Keywords

hepatic impairment

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)

  Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing

  From pre-dose on Day 1 until 96h post-dose (Day 5)

• Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)

  Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing

  From pre-dose on Day 1 until 96h post-dose (Day 5)

• Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)

  Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing

  From pre-dose on Day 1 until 96h post-dose (Day 5)

Secondary Outcomes (1)

• Number of Participants With Adverse Events, Serious Adverse Events and Death

  From the screening visit until Day 5

Study Arms (3)

Group 1: mild hepatic impairment

EXPERIMENTAL

LCZ696 200 mg, given as a single oral dose

Drug: LCZ696

Group 2: moderate hepatic impairment

EXPERIMENTAL

LCZ696 200 mg, given as a single oral dose

Drug: LCZ696

Group 3: healthy volunteers

EXPERIMENTAL

LCZ696 200 mg, given as a single oral dose. Each healthy volunteer will match in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in groups 1 and 2

Drug: LCZ696

Interventions

LCZ696 DRUG

Group 1: mild hepatic impairment; Group 2: moderate hepatic impairment; Group 3: healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• Male and female subjects aged 18-75 years.
• Body weight at least 55 kg with a body mass index between 18-35 kg/m2.
• Hepatic impairment subjects:
• Mild or moderate hepatic impairment.

You may not qualify if:

• All subjects:
• Clinical manifestations of postural symptomatic hypotension at screening or baseline.
• History of hypersensitivity to LCZ696 or to drugs of similar classes.
• Hepatic impairment subjects:
• Hepatic impairment due to non-liver disease.
• Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing.
• Encephalopathyy Stage III or IV.
• Primary biliary liver cirrhosis or biliary obstruction.
• History of gastro-intestinal bleeding within 3 months prior to screening.
• Healthy subjects:
• Any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
• Use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Grünstadt, D-67269, Germany

Location

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 10, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-07

Locations

DE (1)