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

Colonoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583713
• Other study ID #: BLI-800-202
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 20, 2007
• Last updated: October 29, 2010
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2010
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Drug:
• BLI-800
BLI-800 oral solution (two doses)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax)		1 day	No
Primary	Time to Maximum Concentration		1 day	No
Primary	Terminal Half-life		1 day	No
Primary	Area Under the Curve for the 24-hour Dosing Interval		1 day	No
Primary	Elimination Rate Constant		1 day	No
Secondary	Urinary Sulfate Concentration		pre-dose to 6 days post-dose	No