Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment

NCT ID: NCT01727128

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-08-31

Brief Summary

To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment

Conditions

Hepatic Impairment

Keywords

Hepatic impairment; Clinical pharmacology study; Volunteer study

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mild Hepatic Impaired Group

Subjects can only be enroled into this group if they fit the Child -Pugh score criteria of severity category - mildly hepatically impaired

Group Type: EXPERIMENTAL

BKM120

Intervention Type: DRUG

Moderate Hepatic Impaired group

Subjects can only be enroled into this group if they fit the Child -Pugh score criteria of severity category - moderately hepatically impaired

Group Type: EXPERIMENTAL

BKM120

Intervention Type: DRUG

Severe Hepatic Impaired Group

Subjects can only be enroled into this group if they fit the Child -Pugh score criteria of severity category - Severely hepatically impaired

Group Type: EXPERIMENTAL

BKM120

Intervention Type: DRUG

Control Group

Matching healthy control subjects who do not have hepatic impairment and are matched to the hepatic impaired subjects by sex, age, gender and BMI

Group Type: EXPERIMENTAL

BKM120

Intervention Type: DRUG

Interventions

BKM120

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Subjects should be matched to the hepatic impaired subjects of group 2 in gender, age (± 10 years), weight (± 20%), and BMI (±5%)

• 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Moscow, , Russia

Countries

South Africa; Bulgaria; Germany; Russia

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12183

Results for CBKM120C2104 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

2011-002311-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBKM120C2104

Identifier Type: -

Identifier Source: org_study_id