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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904214
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 recommendations for subjects with renal impairment

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: BAF312 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : July 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: severe renal impairmnt Drug: BAF312
Treatment with a single oral dose of 0.25 mg BAF312

Experimental: moderate renal impairment Drug: BAF312
Treatment with a single oral dose of 0.25 mg BAF312

Experimental: mild renal impairment Drug: BAF312
Treatment with a single oral dose of 0.25 mg BAF312

Experimental: healthy subjects Drug: BAF312
Treatment with a single oral dose of 0.25 mg BAF312




Primary Outcome Measures :
  1. Pharmacokinetic parameters of BAF312 and selected metabolites [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, and 312 hours post dose ]
    The pharmacokineticsof BAF312 will be studied in plasma up to 312 (+/-24) hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, and 312 (+/-24) hours post dose. Selected metabolites will also be quantified using the same samples as described above. Free plasma circulating fraction of BAF312 will also be investigated to assess whether protein binding is affected by renal impairment. For this purpose a separate blood sample will be taken at the following time point: 4 hours post-dose.


Secondary Outcome Measures :
  1. Number of participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Day 1 - Day 14 ]
    Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, (serious) adverse event monitoring.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904214


Locations
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United States, Florida
Novartis Investigative Site
Orlando, Florida, United States, 32809
Romania
Novartis Investigative Site
Bucuresti, Romania
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01904214    
Other Study ID Numbers: CBAF312A2129
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
renal impairement
pharmacokinetics
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases