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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00583713
• Date of registration: 20/12/2007
• Primary sponsor: Braintree Laboratories
• Public title: An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters
• Date of first enrolment: August 2007
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00583713
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Russell Pelham, Ph.D.
• Affiliation: Braintree Laboratories, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bowel Preparation

Colonoscopy

Intervention(s)

Drug: BLI-800

Primary Outcome(s)

Area Under the Curve for the 24-hour Dosing Interval [Time Frame: 1 day]

Elimination Rate Constant [Time Frame: 1 day]

Maximum Observed Concentration (Cmax) [Time Frame: 1 day]

Terminal Half-life [Time Frame: 1 day]

Time to Maximum Concentration [Time Frame: 1 day]

Secondary Outcome(s)

Urinary Sulfate Concentration [Time Frame: pre-dose to 6 days post-dose]

Secondary ID(s)

BLI-800-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors