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An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00583713
First received: December 20, 2007
Last updated: October 29, 2010
Last verified: October 2010
History of Changes
Results First Received: September 17, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colonoscopy
Bowel Preparation
Intervention: Drug: BLI-800

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Renal Group BLI-800 oral solution in patients with moderate renal impairment
Healthy Volunteers BLI-800 oral solution in healthy volunteers
Hepatic Group BLI-800 oral solution in patients with mild/moderate hepatic impairment.

Participant Flow:   Overall Study
    Renal Group     Healthy Volunteers     Hepatic Group  
STARTED     6     6     6  
COMPLETED     6     6     6  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Renal Group BLI-800 oral solution in patients with moderate renal impairment
Healthy Volunteers BLI-800 oral solution in healthy volunteers
Hepatic Group BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Total Total of all reporting groups

Baseline Measures
    Renal Group     Healthy Volunteers     Hepatic Group     Total  
Number of Participants  
[units: participants]
 		  6     6     6     18  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     5     6     6     17  
>=65 years     1     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation 		  53.8  ± 7.96     49.0  ± 6.93     51.2  ± 5.74     51.3  ± 6.83  
Gender  
[units: participants]
 		       
Female     3     4     4     11  
Male     3     2     2     7  
Region of Enrollment  
[units: participants]
 		       
United States     6     6     6     18  



  Outcome Measures
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1.  Primary:   Maximum Observed Concentration (Cmax)   [ Time Frame: 1 day ]
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2.  Primary:   Time to Maximum Concentration   [ Time Frame: 1 day ]
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3.  Primary:   Terminal Half-life   [ Time Frame: 1 day ]
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4.  Primary:   Area Under the Curve for the 24-hour Dosing Interval   [ Time Frame: 1 day ]
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5.  Primary:   Elimination Rate Constant   [ Time Frame: 1 day ]
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6.  Secondary:   Urinary Sulfate Concentration   [ Time Frame: pre-dose to 6 days post-dose ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Russell Pelham, PhD
Organization: Braintree Laboratories, Inc.
phone: 781-843-2202
e-mail: rpelham@braintreelabs.com


No publications provided


Responsible Party: Russell Pelham, Ph.D., Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00583713     History of Changes
Other Study ID Numbers: BLI-800-202
Study First Received: December 20, 2007
Results First Received: September 17, 2010
Last Updated: October 29, 2010
Health Authority: United States: Food and Drug Administration