Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 recommenda...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01904214
Start Date
July 1 2013
End Date
November 1 2014
Last Update
December 8 2020
Active Locations (2)
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1
Novartis Investigative Site
Orlando, Florida, United States, 32809
2
Novartis Investigative Site
Bucharest, Romania