To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in
subjects with mild, moderate and severe hepatic impairment
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Full eligibility criteria for NCT01727128
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Subjects should be in good health (except for additional/ specific inclusion criteria related to hepatic impaired subjects) as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests of no significance at screening
Subjects must weigh at least 45 kg to participate in this study, and must have a body mass index (BMI) from (18.5-35.0 kg/m2)
Subjects must be able to communicate well with the investigator, to understand the requirements of the study and agree to use strict contraception for 16 weeks after the last BKM120 dose
--Additional inclusion criteria Group 1 - control healthy subjects
Subjects should be matched to the hepatic impaired subjects of group 2 in gender, age
(± 10 years), weight (± 20%), and BMI (±5%)
--Additional inclusion criteria Group 2 - hepatic impaired subjects
Subjects with physical signs consistent with stable hepatic impairment
Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
(mild , moderate or severe)
Subjects must be free of significant medical disorders unrelated to the subject's hepatic disorder as judged by the investigator.
Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L
Platelet count ≥ 50 x 109 /L
serum creatinine ≤ 1.5 x ULN
Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for the hepatic impaired subjects who due to their liver disease may be affected by significant medical problems which require frequent hospitalizations. Invasive systemic fungal infections need to be fully resolved prior to study entry
Use of tobacco products within 2 weeks prior to dosing or during the study.
Consumption of alcohol within 2 days prior to dosing or during the study
Subjects with known ongoing alcohol and or/drug abuse within 1 month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening and/or at baseline
Subjects not willing to avoid certain study prohibited food, drink, over the counter medicines and supplements
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
Medical history of cardiac disease and/or clinically significant ECG abnormalities.
History of clinically significant hematologic, renal, endocrinologic, pulmonary cardiovascular, hepatic, or allergic disease medically documented
Medical history of relevant psychiatric disorders
Subjects with Diabetes Mellitus or subjects with glucose levels out of normal range as judge by the investigator
History of immunodeficiency diseases, including Human Immunodeficiency Virus (HIV), as confirmed by (HIV-1, HIV-2) test
Additional exclusion criteria Group 1 (matched healthy control subjects) History or presence of liver disease or liver injury as indicated by an abnormal liver function profile A positive Hepatitis C test or a positive Hepatitis B surface antigen (HBsAg)
Additional exclusion criteria Group 2- hepatic impaired subjects
Subjects with clinically significant abnormal findings, not consistent with clinical disease, upon physical examination, ECG or laboratory evaluation
Any evidence of progressive liver disease (within the last 4 weeks prior to the screening visit) as indicated by liver transaminases, alkaline phosphatase and GGT or a ≥ 50% worsening of serum bilirubin or prothrombin time
Total bilirubin > 6mg/dl
Subject has ascites requiring intervention
All locations for NCT01727128
Novartis Investigative Site
Sofia, Bulgaria, 1618
Novartis Investigative Site
Berlin, Germany, 14050
Russian Federation (1)
Novartis Investigative Site
Moscow, Russian Federation, 117198
View full eligibility
Tris trial is registered with FDA with number: NCT01727128. The sponsor of the trial is Novartis Pharmaceuticals and it is looking for 31 volunteers for the current phase.
Official trial title: A Phase I, Multicenter, Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of BKM120 in Subjects With Mild, Moderate and Severe Hepatic Impairmen
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