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

NCT00583713 | Completed Phase 1 Results

• 1 other identifier: BLI-800-202
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Urinary Sulfate Concentration

  pre-dose to 6 days post-dose

Study Arms (3)

Renal Group

EXPERIMENTAL

Patients with moderate renal impairment

Drug: BLI-800

Healthy volunteers

ACTIVE COMPARATOR

Healthy volunteers

Drug: BLI-800

Hepatic Group

EXPERIMENTAL

Patients with mild/moderate hepatic impairment.

Drug: BLI-800

Interventions

BLI-800 DRUG

BLI-800 oral solution (two doses)

Healthy volunteers; Hepatic Group; Renal Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (1)

Unknown Facility

Minneapolis, Minnesota, United States

Location

Results Point of Contact

• Title: Russell Pelham, PhD
• Organization: Braintree Laboratories, Inc.

rpelham@braintreelabs.com

781-843-2202

Study Officials

• Russell Pelham, Ph.D.

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 11, 2010
• Results First Posted: November 1, 2010

Record last verified: 2010-10

Locations

US (1)