Phase 2
N=32
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01621633 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: 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) — 2540; 6200; 1580; 1740 ng*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCZ696 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
2540; 6200; 1580; 1740; 118000; 173000 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan) |
2540; 6200; 1590; 1740; 121000; 187000 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan) |
2530; 4430; 1510; 1410; 7730; 6690 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Death |
0; 2; 0; 0; 0; 0 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01621633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.