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

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: NCT00583713
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : November 1, 2010
Last Update Posted : November 11, 2010
Sponsor:
Information provided by:
Braintree Laboratories

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 31, 2007
Results First Submitted Date  ICMJE September 17, 2010
Results First Posted Date  ICMJE November 1, 2010
Last Update Posted Date November 11, 2010
Study Start Date  ICMJE August 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2010)
  • Maximum Observed Concentration (Cmax) [ Time Frame: 1 day ]
  • Time to Maximum Concentration [ Time Frame: 1 day ]
  • Terminal Half-life [ Time Frame: 1 day ]
  • Area Under the Curve for the 24-hour Dosing Interval [ Time Frame: 1 day ]
  • Elimination Rate Constant [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
Chemistry, hematology and urinalysis measurements [ Time Frame: 6 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2010)
Urinary Sulfate Concentration [ Time Frame: pre-dose to 6 days post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
adverse events [ Time Frame: 6 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters
Official Title  ICMJE Not Provided
Brief Summary To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in two groups of patients and one group of healthy controls. The patient groups will be those with mild or moderate hepatic impairment or moderate renal disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colonoscopy
  • Bowel Preparation
Intervention  ICMJE Drug: BLI-800
BLI-800 oral solution (two doses)
Study Arms  ICMJE
  • Experimental: Renal Group
    Patients with moderate renal impairment
    Intervention: Drug: BLI-800
  • Active Comparator: Healthy volunteers
    Healthy volunteers
    Intervention: Drug: BLI-800
  • Experimental: Hepatic Group
    Patients with mild/moderate hepatic impairment.
    Intervention: Drug: BLI-800
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2007)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are male or female adults who are:

    • With Child-Pugh Hepatic Dysfunction Stage A or B, or
    • With Moderate Renal Disease or
    • Healthy subjects matched to those who are enrolled in this study
  • Subjects who are considered to have only clinically non-significant conditions, as judged by the Principal Investigator and based on physical examination, laboratory profiles, medical history and ECG.
  • Female subjects who are not surgically sterile (i.e., having had a hysterectomy, bilateral oophorectomy or tubal ligation) or who are not at least 2 years naturally postmenopausal must agree to use an acceptable form of contraception.
  • Provide voluntary consent in writing to participate in this study.

Exclusion Criteria:

  • Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects who, in the opinion of the Principal Investigator, have uncontrolled clinically significant pre-existing electrolyte disturbances, based on the Screening visit laboratory results.
  • Subjects with present or prior NYHA Functional Classification grade III or IV congestive heart failure.
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  • Subjects of childbearing potential who refuse a pregnancy test.
  • Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
  • Subjects with a history of allergic or adverse response to any BLI-800 component.
  • Subjects who donated more than one pint of blood within 30 days prior to the study.
  • Subjects who donated plasma within 7 days prior to the study.
  • Subjects who had an abnormal diet or substantial changes in eating habits within 30 days prior to the start of the study.
  • Subjects who have had a bowel cleansing procedure within the past month or who have taken a laxative within the 5 days (120 hours) prior to dosing or who require a laxative every day.
  • Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583713
Other Study ID Numbers  ICMJE BLI-800-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Russell Pelham, Ph.D., Braintree Laboratories, Inc.
Study Sponsor  ICMJE Braintree Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Russell Pelham, Ph.D. Braintree Laboratories, Inc.
PRS Account Braintree Laboratories
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP