Clinical trial · Interventional
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Mild and Moderate Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
NCT01569815CI-TRIAL-00019517completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mild and Moderate Renal Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCZ696 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LCZ696 400 mg
- description
- LCZ696 400 mg once daily for 5 days
- interventionNames
- Drug: LCZ696
Primary outcomes (8)
- measure
- Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
- timeFrame
- Day 1 and day 5
- description
- Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)
- measure
- Maximum Peak Plasma Concentration (Cmax) Observed After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
- timeFrame
- Day 1, day 5
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male, and female subjects of non-child bearing potential, 2. Subjects were to weigh at least 50 kg to participate in the study, 3. and body mass index \< 40 kg/m2 4. Subjects were able to communicate well with the investigator, to understand and comply with the requirements of the study; 5. Subjects were able to understand and sign the written informed consent; For renal insufficient subjects: 1. stable renal disease without evidence of renal progressive * mild renal function: calculated CrCl of 50-≤80 mL/min * moderate renal function: calculated CrCl of 30-\<50 mL/min 2. Vital signs: * oral body temperature between 35.0-37.8 °C * systolic blood pressure, 95-180 mm Hg * diastolic blood pressure, 60-110 mm Hg * pulse rate, 54-95 bpm For healthy subjects only 1. A serum creatinine with a calculated CrCl of \>80 mL/min 2. Vital signs: * oral body temperature between 35.0-37.2 °C * systolic blood pressure, 95-140 mm Hg * diastolic blood pressure, 60-100 mm Hg * pulse rate, 45-90 bpm Exclusion Criteria: 1. Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9 substrates, potassium-sparing diuretics; 2. Smokers; 3. History of renal transplant at any time in the past and on immunosuppressant therapy; 4. Dialysis patients; 5. Medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome; 6. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance; Other protocol defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.