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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01456663

Collaborator

(none)

118

Enrollment

Locations

Arm

Duration (Months)

39.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: AFQ056	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

N/A

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AFQ056	Drug: AFQ056

Arm

Intervention/Treatment

Experimental: AFQ056

Drug: AFQ056

Outcome Measures

Primary Outcome Measures

Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups [pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose]
AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F

Secondary Outcome Measures

Measure: : Number of subjects with adverse event in each group [From dose administration (day 1) to 13+/- 2 days after the single dose administration]
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
Measure: Plasma protein binding results of AFQ056 in each groups. [2 hours after single dose administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Orlando	Florida	United States	32809
2	Novartis Investigative Site	Berlin		Germany	10117
3	Novartis Investigative Site	Balatonfured		Hungary	8230