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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: BLI-800

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers	Drug: BLI-800; BLI-800 oral solution (two doses)
Experimental: Renal Group; Patients with moderate renal impairment	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Concentration (Cmax)	1 day
Time to Maximum Concentration	1 day
Terminal Half-life	1 day
Area Under the Curve for the 24-hour Dosing Interval	1 day
Elimination Rate Constant	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Urinary Sulfate Concentration	pre-dose to 6 days post-dose

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: Russell Pelham, Ph.D., Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): December 31, 2007

Study Record Updates

• Last Update Posted (Estimate): November 11, 2010
• Last Update Submitted That Met QC Criteria: October 29, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: BLI-800-202