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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01456663
First received: August 24, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Hepatic Impairment
Drug: AFQ056
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
    AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F


Secondary Outcome Measures:
  • Measure: : Number of subjects with adverse event in each group [ Time Frame: From dose administration (day 1) to 13+/- 2 days after the single dose administration ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 2 hours after single dose administration ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFQ056 Drug: AFQ056

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456663

Locations
United States, Florida
Novartis Investigative Site
Orlando, Florida, United States, 32809
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Hungary
Novartis Investigative Site
Balatonfured, Hungary, 8230
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01456663     History of Changes
Other Study ID Numbers: CAFQ056A2123, 2011-000748-28
Study First Received: August 24, 2011
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy

Keywords provided by Novartis:
AFQ056
Hepatic impairment
Hepatic impaired

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014