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

August 24, 2011
February 4, 2013
May 2011
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01456663 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: Open Label
Hepatic Impairment
Drug: AFQ056
Experimental: AFQ056
Intervention: Drug: AFQ056
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
July 2012
July 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hungary
 
NCT01456663
CAFQ056A2123, 2011-000748-28
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP