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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 study

Area 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

Page last updated: August 23, 2015

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