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

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

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

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: AFQ056

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Novartis Investigative Site
• Hungary
  • Balatonfured, Hungary, 8230
    • Novartis Investigative Site
• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AFQ056	Drug: AFQ056

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measure: Plasma protein binding results of AFQ056 in each groups.		2 hours after single dose administration

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Hepatic impairment; AFQ056; Hepatic impaired
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: CAFQ056A2123; 2011-000748-28 (EudraCT Number)