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Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01565902
First received: March 26, 2012
Last updated: January 8, 2015
Last verified: January 2015
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Hepatic Impairment
Intervention: Drug: BAF312

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Up to forty-eight subjects were planned to be enrolled in four groups. A total of 40 subjects were enrolled and completed the study. All subjects were included in the safety and PK analysis. However, only 38 subjects were included for primary PK analysis based on matched pair analysis

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To potentially reduce the number of healthy subjects exposed to BAF312, study allowed for multiple matching of subjects with hepatic impairment to healthy subjects. During the study, 2 healthy subjects were not matched to any of the subjects with hepatic impairment due to a retrospective identification of a better matching partner

Reporting Groups
  Description
Mild Hepatically Impaired 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
Severe Hepatically Impaired 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

Participant Flow:   Overall Study
    Mild Hepatically Impaired     Moderate Hepatically Impaired     Severe Hepatically Impaired     Matched Healthy Subjects  
STARTED     8     8     8     16  
COMPLETED     8     8     8     16  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mild Hepatically Impaired 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
Severe Hepatically Impaired 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
Total Total of all reporting groups

Baseline Measures
    Mild Hepatically Impaired     Moderate Hepatically Impaired     Severe Hepatically Impaired     Matched Healthy Subjects     Total  
Number of Participants  
[units: participants]
  8     8     8     16     40  
Age  
[units: Years]
Mean ± Standard Deviation
  53.9  ± 6.20     47.8  ± 6.30     51.8  ± 3.41     50.1  ± 5.50     50.7  ± 5.65  
Gender  
[units: Participants]
         
Female     2     2     4     6     14  
Male     6     6     4     10     26  



  Outcome Measures
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1.  Primary:   Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)   [ 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, 312, 408 and 504 hours post dose. ]

2.  Primary:   Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)   [ 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, 312, 408 and 504 hours post dose. ]

3.  Primary:   Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)   [ 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, 312, 408 and 504 hours post dose ]

4.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312   [ Time Frame: Day -1 to 22 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01565902     History of Changes
Other Study ID Numbers: CBAF312A2122, 2012-000562-37
Study First Received: March 26, 2012
Results First Received: December 12, 2014
Last Updated: January 8, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy