Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

NCT ID: NCT01565902

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-03-31

Brief Summary

This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.

Conditions

Hepatic Impairment

Keywords

BAF312; Pharmacokinetics; Hepatic impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mild hepatically impaired

Treatment with a single oral dose of 0.25 mg BAF312

Group Type: EXPERIMENTAL

BAF312

Intervention Type: DRUG

Treatment with a single oral dose of 0.25 mg BAF312

Moderate hepatically impaired

Treatment with a single oral dose of 0.25 mg BAF312

Group Type: EXPERIMENTAL

BAF312

Intervention Type: DRUG

Treatment with a single oral dose of 0.25 mg BAF312

Severe hepatically impaired

Treatment with a single oral dose of 0.25 mg BAF312

Group Type: EXPERIMENTAL

BAF312

Intervention Type: DRUG

Treatment with a single oral dose of 0.25 mg BAF312

Matched healthy subjects

Treatment with a single oral dose of 0.25 mg BAF312

Group Type: EXPERIMENTAL

BAF312

Intervention Type: DRUG

Treatment with a single oral dose of 0.25 mg BAF312

Interventions

BAF312

Treatment with a single oral dose of 0.25 mg BAF312

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All subjects:

• Male and female Caucasian subjects 18 to 70 years of age
• At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
• CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Hepatic impairment:

• Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria

All subjects

• Hepatic impairment due to non-liver disease.
• Use of other investigational drugs within certain timelines
• Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
• History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
• History of cardiac catheter ablation.
• Women of child-bearing potential
• History of malignancy of any organ system
• Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
• History or presence of symptomatic postural hypotension or syncope.
• Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
• Clinically significant infection or recent vaccination with live-attenuated vaccines.
• History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
• History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

• History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
• 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.
• Treatment with certain drugs

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, drugs, or which may jeopardize the subject in case of participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Balatonfüred, , Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Moscow, , Russia

Countries

Germany; Hungary; Russia

Related Links

https://www.dustri.com/nc/article-response-page.html?artId=14609&doi=10.5414%2FCP202588

Publication from the International Journal of Clinical Pharmacology and Therapeutics

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13203

Results for CBAF312A2122 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

2012-000562-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBAF312A2122

Identifier Type: -

Identifier Source: org_study_id