A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Hepatic Impairment Clinical Trial

Official title:

A Single-dose, Open-label, Parallel Study to Assess the Pharmacokinetics of AFQ056 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456663
• Other study ID #: CAFQ056A2123
• Secondary ID: 2011-000748-28
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Groups 1, 2, 3 and 4 (all subjects)

• Male and female Caucasian subjects

• Group 1, 2 and 3 (subjects with hepatic impairment)

• Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening

• Group 4 (healthy subjects)

• Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.

Exclusion Criteria:

• Groups 1, 2, 3 and 4 (all subjects)

• Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.

• Group 1, 2 and 3 (subjects with hepatic impairment)

• History of drug or alcohol abuse within 3 months prior to screening

• History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.

• Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.

• History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3).

• Documented presence of a porto-systemic shunt.

• Documented presence of esophagus varices (stage III or IV).

• Group 4 (healthy subjects)

• History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.

• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.

• 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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• AFQ056

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Hungary	Novartis Investigative Site	Balatonfured
United States	Novartis Investigative Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups	AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F	pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose
Secondary	Measure: : Number of subjects with adverse event in each group	Number and type of adverse events, number and type of findings in standard laboratory results, special laboratory results (Hypothaliamic-pituitary axis, porphyrin profile) electrocardiogram holters, or in vital signs	From dose administration (day 1) to 13+/- 2 days after the single dose administration
Secondary	Measure: Plasma protein binding results of AFQ056 in each groups.		2 hours after single dose administration

External Links

•   Results for CAFQ056A2123 can be found on the Novartis Clinical Trial Results website