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
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Bowel Preparation
Drug: BLI-800
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Maximum Observed Concentration (Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Time to Maximum Concentration [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Terminal Half-life [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Area Under the Curve for the 24-hour Dosing Interval [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Elimination Rate Constant [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary Sulfate Concentration [ Time Frame: pre-dose to 6 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Group
Patients with moderate renal impairment
Drug: BLI-800
BLI-800 oral solution (two doses)
Active Comparator: Healthy volunteers
Healthy volunteers
Drug: BLI-800
BLI-800 oral solution (two doses)
Experimental: Hepatic Group
Patients with mild/moderate hepatic impairment.
Drug: BLI-800
BLI-800 oral solution (two doses)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583713

Locations
United States, Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: Russell Pelham, Ph.D. Braintree Laboratories, Inc.
  More Information

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

ClinicalTrials.gov processed this record on April 22, 2014