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

NCT ID: NCT00583713

Last Updated: 2010-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-06-30

Brief 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.

Conditions

Colonoscopy; Bowel Preparation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal Group

Patients with moderate renal impairment

Group Type: EXPERIMENTAL

BLI-800

Intervention Type: DRUG

BLI-800 oral solution (two doses)

Healthy volunteers

Healthy volunteers

Group Type: ACTIVE_COMPARATOR

BLI-800

Intervention Type: DRUG

BLI-800 oral solution (two doses)

Hepatic Group

Patients with mild/moderate hepatic impairment.

Group Type: EXPERIMENTAL

BLI-800

Intervention Type: DRUG

BLI-800 oral solution (two doses)

Interventions

BLI-800

BLI-800 oral solution (two doses)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Braintree Laboratories, Inc.

Principal Investigators

Russell Pelham, Ph.D.

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

BLI-800-202

Identifier Type: -

Identifier Source: org_study_id