Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Impairment
Intervention: LCQ908 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of
hepatic impairment to healthy subjects.
Clinical Details
Official title: An Open-label, Single Dose, Parallel-group Study to Evaluate the Pharmacokinetics of LCQ908 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared to Age, Gender and Weight-matched Healthy Volunteers.
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908 for part I of the studyArea under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908 for part I of the study Maximum plasma concentration of LCQ908 (Cmax) for Part I of the study The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration for Part I of the study Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908 for Part II of the study Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908 for Part II of the study Maximum plasma concentration of LCQ908 (Cmax) for Part II of the study The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration for Part II of the study
Secondary outcome: Number of participants with adverse events, serious adverse events and death (for both Part I and Part II)Time to maximum plasma concentration of LCQ908 (Tmax) (for both Part I and Part II) The time required for the concentration of the drug to reach half of its original value (T1/2) (for both Part I and Part II) The apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration (Vz/F) (for both Part I and Part II) LCQ908 protein binding: unbound area under curve (AUCu) of LCQ908 (for both Part I and Part II) LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908 (for both Part I and Part II) LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration (for both Part I and Part II)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
Individuals with hepatic impairment only
• Hepatic impairment evidenced by a Child-Pugh score
- Mild hepatic impairment defined Child-Pugh Class A (5-6 points)
- Moderate hepatic impairment defined Child-Pugh Class B (7-9 points)
- Severe hepatic impairment defined Child-Pugh Class C (10-15 points).
Healthy subjects only
• Good health determined.
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 hepatic impairment
- History of drug or alcohol abuse within 3 months prior to dosing.
- History or presence of significant uncontrolled disease of any major organ class.
- Any surgical or medical condition other than hepatic impairment which might alter the
drug metabolism.
Healthy subjects
- History or presence of significant uncontrolled disease of any major organ class.
- Any surgical or medical condition other than hepatic impairment which might alter the
drug metabolism.
- 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/exclusion criteria may apply.
Locations and Contacts
Novartis Investigative Site, Miami, Florida 33136, United States
Novartis Investigative Site, Orlando, Florida 32809, United States
Additional Information
Starting date: April 2012
Last updated: May 23, 2013
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