Renal Impairment
Conditions
Keywords
LCQ908, Renal Impairment, Pharmacokinetics
Brief summary
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects
Interventions
DRUGLCQ908
Participants will receive a single oral dose of LCQ908
Sponsors
Novartis Pharmaceuticals
Study design
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals with renal impairment only * Estimated Creatinine Clearance (CLcr) by the Cockroft-Gault equation ≤80mL/min; * Mild renal impairment defined as CLcr 50-80 mL/min * Moderate renal impairment defined as CLcr 30-50 mL/min * Severe renal impairment defined as CLcr \<30 mL/min * Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation \>80mL/min
Exclusion criteria
* All Individuals * A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome. * Female subjects must be of non child bearing potential or use an effective method of contraception. * Individuals with renal impairment * Renal transplant at any time. * Subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months. * History of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days. * Any medication that is contraindicated in moderate or severe renally impaired population * Healthy subjects * History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) * Evidence of urinary obstruction or difficulty in voiding at screening * History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| Maximum plasma concentration (Cmax) of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time required for the concentration of the drug to reach half of its original value | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing | — |
| Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing | — |
| Number of participants with adverse events (AEs), serious adverse events (SAEs) and death | Day 29 | AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital abnormalities or birth defects, or are other conditions which in the judgment of investigators represent significant hazards. |
| LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908 | 10 and 24 hours | — |
| LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration | 10 and 24 hours | — |
| LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908 | 10 and 24 hours | — |
| The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing | — |
| Time to maximum plasma concentration of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing | — |
Countries
United States
Outcome results
None listed