A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Novartis

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: BAF312

Study type: Interventional

Funder types: Industry

Identifiers

NCT01904214

CBAF312A2129

Details and patient eligibility

About

to quantify the effect of different degrees of renal impairment on the pharmacokinetics of BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal impairment

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All subjects:

• At least 50 kg and body mass index (BMI) within 18-38 kg/m2.
• CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Renal impairment:

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

Exclusion criteria

All subjects

• 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.
• Women of child-bearing potential
• History of malignancy of any organ system
• 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.

Renal 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 renal 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.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

severe renal impairmnt

Experimental group

Treatment:

Drug: BAF312

moderate renal impairment

Experimental group

Treatment:

Drug: BAF312

mild renal impairment

Experimental group

Treatment:

Drug: BAF312

healthy subjects

Experimental group

Treatment:

Drug: BAF312