ColonoscopyPhase 1/2NCT00583713
An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters
A Phase 1/2 study testing BLI-800 in people with Colonoscopy and Bowel Preparation, run by Braintree Laboratories at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- BLI-800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- BLI-800
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI-800Drug
BLI-800 oral solution (two doses)
| Study group | Role | What they receive |
|---|---|---|
| Renal Group | Experimental | Patients with moderate renal impairment Receives: Drug: BLI-800 |
| Healthy volunteers | Active comparator | Healthy volunteers Receives: Drug: BLI-800 |
| Hepatic Group | Experimental | Patients with mild/moderate hepatic impairment. Receives: Drug: BLI-800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax)
Measured: 1 day
Time to Maximum Concentration
Measured: 1 day
Terminal Half-life
Measured: 1 day
Area Under the Curve for the 24-hour Dosing Interval
Measured: 1 day
Elimination Rate Constant
Measured: 1 day
Secondary outcomes (1)
Urinary Sulfate Concentration
Measured: pre-dose to 6 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Russell Pelham, Ph.D., Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583713
- Sponsor's protocol ID
- BLI-800-202
- Status last verified
- Oct 2010
- First submitted
- 20 Dec 2007
- Last updated
- 11 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters
- ClinicalTrials.gov ID
- NCT00583713
- Acronym / sponsor ID
- BLI-800-202
- Conditions
- Colonoscopy, Bowel Preparation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 1 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Renal Group | Experimental | Drug: BLI-800Patients with moderate renal impairment |
| Healthy volunteers | Active comparator | Drug: BLI-800Healthy volunteers |
| Hepatic Group | Experimental | Drug: BLI-800Patients with mild/moderate hepatic impairment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are male or female adults who are:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLI-800BLI-800 oral solution (two doses) | Drug | Healthy volunteers, Hepatic Group, Renal Group |
Primary outcome
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
1 secondary outcome
Urinary Sulfate Concentration
Time frame: pre-dose to 6 days post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Pelham, Ph.D. study director
Braintree Laboratories, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BLI-800 in people with Colonoscopy and Bowel Preparation, run by Braintree Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Concentration (Cmax) (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.