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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colonoscopy
Bowel Preparation
Intervention Drug: BLI-800
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description BLI-800 oral solution in patients with moderate renal impairment BLI-800 oral solution in healthy volunteers BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Period Title: Overall Study
Started 6 6 6
Completed 6 6 6
Not Completed 0 0 0
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group Total
Hide Arm/Group Description BLI-800 oral solution in patients with moderate renal impairment BLI-800 oral solution in healthy volunteers BLI-800 oral solution in patients with mild/moderate hepatic impairment. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
6
 100.0%
6
 100.0%
17
  94.4%
>=65 years
1
  16.7%
0
   0.0%
0
   0.0%
1
   5.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 18 participants
53.8  (7.96) 49.0  (6.93) 51.2  (5.74) 51.3  (6.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 18 participants
Female
3
  50.0%
4
  66.7%
4
  66.7%
11
  61.1%
Male
3
  50.0%
2
  33.3%
2
  33.3%
7
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 18 participants
6 6 6 18
1.Primary Outcome
Title Maximum Observed Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description:
BLI-800 oral solution in patients with moderate renal impairment
BLI-800 oral solution in healthy volunteers
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: µmol/L
717.0  (270.84) 499.5  (165.00) 560.2  (152.75)
2.Primary Outcome
Title Time to Maximum Concentration
Hide Description [Not Specified]
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description:
BLI-800 oral solution in patients with moderate renal impairment
BLI-800 oral solution in healthy volunteers
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
17.5  (2.95) 16.8  (8.16) 14.2  (5.00)
3.Primary Outcome
Title Terminal Half-life
Hide Description [Not Specified]
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description:
BLI-800 oral solution in patients with moderate renal impairment
BLI-800 oral solution in healthy volunteers
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
10.16  (9.32) 8.51  (4.57) 5.58  (2.31)
4.Primary Outcome
Title Area Under the Curve for the 24-hour Dosing Interval
Hide Description [Not Specified]
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description:
BLI-800 oral solution in patients with moderate renal impairment
BLI-800 oral solution in healthy volunteers
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: µmol*hr/L
12,332.95  (4,193.54) 8,029.88  (3,424.42) 10,751.75  (2,878.17)
5.Primary Outcome
Title Elimination Rate Constant
Hide Description [Not Specified]
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description:
BLI-800 oral solution in patients with moderate renal impairment
BLI-800 oral solution in healthy volunteers
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.127  (0.09) 0.107  (0.06) 0.141  (0.050)
6.Secondary Outcome
Title Urinary Sulfate Concentration
Hide Description [Not Specified]
Time Frame pre-dose to 6 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description:
BLI-800 oral solution in patients with moderate renal impairment
BLI-800 oral solution in healthy volunteers
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
Pre-dose 1 91.58  (40.12) 131.20  (46.98) 86.92  (50.09)
Day 3 135.53  (86.28) 145.62  (111.02) 89.83  (67.81)
Day 6 96.98  (47.61) 134.65  (74.72) 70.82  (83.64)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Renal Group Healthy Volunteers Hepatic Group
Hide Arm/Group Description BLI-800 oral solution in patients with moderate renal impairment BLI-800 oral solution in healthy volunteers BLI-800 oral solution in patients with mild/moderate hepatic impairment.
All-Cause Mortality
Renal Group Healthy Volunteers Hepatic Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Renal Group Healthy Volunteers Hepatic Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Renal Group Healthy Volunteers Hepatic Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   4/6 (66.67%)   5/6 (83.33%) 
Gastrointestinal disorders       
Abdominal cramping *  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%) 
Nausea *  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%) 
Constipation *  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Emesis *  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Perianal irritation *  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders       
Chills *  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Fatigue *  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations       
Abnormal urinalysis   0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Elevated serum creatinine   0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Metabolism and nutrition disorders       
Symptomatic hypoglycemia *  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders       
Headache *  1/6 (16.67%)  3/6 (50.00%)  3/6 (50.00%) 
Respiratory, thoracic and mediastinal disorders       
Chest congestion *  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Sore throat *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Russell Pelham, PhD
Organization: Braintree Laboratories, Inc.
Phone: 781-843-2202
EMail: rpelham@braintreelabs.com
Layout table for additonal information
Responsible Party: Russell Pelham, Ph.D., Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00583713    
Other Study ID Numbers: BLI-800-202
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: September 17, 2010
Results First Posted: November 1, 2010
Last Update Posted: November 11, 2010