CompletedNCT00583713Updated Nov 11, 2010Results posted

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

A Phase 1/2 interventional study of BLI-800 in Colonoscopy and Bowel Preparation, sponsored by Braintree Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-11.

Sponsored by Braintree Laboratories · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 18
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Colonoscopy
Bowel Preparation

In context

Lead sponsor

Braintree Laboratories is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Experimental
Renal Group
Patients with moderate renal impairment
Drug: BLI-800
Active comparator
Healthy volunteers
Healthy volunteers
Drug: BLI-800
Experimental
Hepatic Group
Patients with mild/moderate hepatic impairment.
Drug: BLI-800

Interventions

DrugBLI-800
BLI-800 oral solution (two doses)

What researchers measure

Primary outcomes

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

Secondary outcomes

Urinary Sulfate Concentration
Time frame: pre-dose to 6 days post-dose

Results

Posted Nov 1, 2010

Participant flow

Participant flow — Overall Study
Milestone	Renal Group	Healthy Volunteers	Hepatic Group
Started	6	6	6
Completed	6	6	6
Not completed	0	0	0

Outcome measures

PrimaryMaximum Observed Concentration (Cmax)

Time frame:: 1 day
Reported as:: Mean · µmol/L

Maximum Observed Concentration (Cmax)
µmol/L	Renal Group	Healthy Volunteers	Hepatic Group
Maximum Observed Concentration (Cmax)	717.0 ± 270.84	499.5 ± 165.00	560.2 ± 152.75

SecondaryUrinary Sulfate Concentration

Time frame:: pre-dose to 6 days post-dose
Reported as:: Mean · mg/dL

Urinary Sulfate Concentration
mg/dL	Renal Group	Healthy Volunteers	Hepatic Group
Pre-dose 1	91.58 ± 40.12	131.20 ± 46.98	86.92 ± 50.09
Day 3	135.53 ± 86.28	145.62 ± 111.02	89.83 ± 67.81
Day 6	96.98 ± 47.61	134.65 ± 74.72	70.82 ± 83.64

PrimaryTime to Maximum Concentration

Time frame:: 1 day
Reported as:: Mean · hours

Time to Maximum Concentration
hours	Renal Group	Healthy Volunteers	Hepatic Group
Time to Maximum Concentration	17.5 ± 2.95	16.8 ± 8.16	14.2 ± 5.00

PrimaryTerminal Half-life

Time frame:: 1 day
Reported as:: Mean · hours

Terminal Half-life
hours	Renal Group	Healthy Volunteers	Hepatic Group
Terminal Half-life	10.16 ± 9.32	8.51 ± 4.57	5.58 ± 2.31

PrimaryArea Under the Curve for the 24-hour Dosing Interval

Time frame:: 1 day
Reported as:: Mean · µmol*hr/L

Area Under the Curve for the 24-hour Dosing Interval
µmol*hr/L	Renal Group	Healthy Volunteers	Hepatic Group
Area Under the Curve for the 24-hour Dosing Interval	12,332.95 ± 4,193.54	8,029.88 ± 3,424.42	10,751.75 ± 2,878.17

PrimaryElimination Rate Constant

Time frame:: 1 day
Reported as:: Mean · 1/hr

Elimination Rate Constant
1/hr	Renal Group	Healthy Volunteers	Hepatic Group
Elimination Rate Constant	0.127 ± 0.09	0.107 ± 0.06	0.141 ± 0.050

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Renal Group	—	0/6 (0%)	5/6 (83.3%)
Healthy Volunteers	—	0/6 (0%)	4/6 (66.7%)
Hepatic Group	—	0/6 (0%)	5/6 (83.3%)

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Renal Group	Healthy Volunteers	Hepatic Group
HeadacheNervous system disorders	1/6	3/6	3/6
NauseaGastrointestinal disorders	2/6	0/6	1/6
Abdominal crampingGastrointestinal disorders	1/6	0/6	1/6
Chest congestionRespiratory, thoracic and mediastinal disorders	0/6	1/6	0/6
ChillsGeneral disorders	0/6	1/6	0/6
ConstipationGastrointestinal disorders	1/6	0/6	0/6
EmesisGastrointestinal disorders	0/6	1/6	0/6
FatigueGeneral disorders	1/6	0/6	0/6
Perianal irritationGastrointestinal disorders	1/6	0/6	0/6
Sore throatRespiratory, thoracic and mediastinal disorders	0/6	0/6	1/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Renal Group	Healthy Volunteers	Hepatic Group	Total
<=18 years	0	0	0	0
Between 18 and 65 years	5	6	6	17
>=65 years	1	0	0	1

Age Continuous
Age Continuous(years)	Renal Group	Healthy Volunteers	Hepatic Group	Total
Mean	53.8 ± 7.96	49.0 ± 6.93	51.2 ± 5.74	51.3 ± 6.83

Sex: Female, Male
Sex: Female, Male(Participants)	Renal Group	Healthy Volunteers	Hepatic Group	Total
Female	3	4	4	11
Male	3	2	2	7

Region of Enrollment
Region of Enrollment(participants)	Renal Group	Healthy Volunteers	Hepatic Group	Total
United States	6	6	6	18

Study locations

1 site

Minneapolis, Minnesota, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00583713
Lead sponsor: Braintree Laboratories
First posted: Dec 31, 2007
Start date: Aug 2007
Primary completion: Apr 2008
Completion: Jun 2008
Results posted: Nov 1, 2010
Last update: Nov 11, 2010

Study contacts

Russell Pelham, Ph.D.

study director · Braintree Laboratories, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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