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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00583713
Enrollment
18
Registered
2007-12-31
Start date
2007-08-31
Completion date
2008-06-30
Last updated
2010-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Bowel Preparation

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.

Interventions

DRUGBLI-800

BLI-800 oral solution (two doses)

Sponsors

Braintree Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frame
Maximum Observed Concentration (Cmax)1 day
Time to Maximum Concentration1 day
Terminal Half-life1 day
Area Under the Curve for the 24-hour Dosing Interval1 day
Elimination Rate Constant1 day

Secondary

MeasureTime frame
Urinary Sulfate Concentrationpre-dose to 6 days post-dose

Countries

United States

Participant flow

Participants by arm

ArmCount
Renal Group
BLI-800 oral solution in patients with moderate renal impairment
6
Healthy Volunteers
BLI-800 oral solution in healthy volunteers
6
Hepatic Group
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
6
Total18

Baseline characteristics

CharacteristicHealthy VolunteersHepatic GroupRenal GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
6 Participants6 Participants5 Participants17 Participants
Age Continuous49.0 years
STANDARD_DEVIATION 6.93
51.2 years
STANDARD_DEVIATION 5.74
53.8 years
STANDARD_DEVIATION 7.96
51.3 years
STANDARD_DEVIATION 6.83
Region of Enrollment
United States
6 participants6 participants6 participants18 participants
Sex: Female, Male
Female
4 Participants4 Participants3 Participants11 Participants
Sex: Female, Male
Male
2 Participants2 Participants3 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
5 / 64 / 65 / 6
serious
Total, serious adverse events
0 / 60 / 60 / 6

Outcome results

Primary

Area Under the Curve for the 24-hour Dosing Interval

Time frame: 1 day

ArmMeasureValue (MEAN)
Renal GroupArea Under the Curve for the 24-hour Dosing Interval12,332.95 µmol*hr/L
Healthy VolunteersArea Under the Curve for the 24-hour Dosing Interval8,029.88 µmol*hr/L
Hepatic GroupArea Under the Curve for the 24-hour Dosing Interval10,751.75 µmol*hr/L
Primary

Elimination Rate Constant

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Renal GroupElimination Rate Constant0.127 1/hrStandard Deviation 0.09
Healthy VolunteersElimination Rate Constant0.107 1/hrStandard Deviation 0.06
Hepatic GroupElimination Rate Constant0.141 1/hrStandard Deviation 0.05
Primary

Maximum Observed Concentration (Cmax)

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Renal GroupMaximum Observed Concentration (Cmax)717.0 µmol/LStandard Deviation 270.84
Healthy VolunteersMaximum Observed Concentration (Cmax)499.5 µmol/LStandard Deviation 165
Hepatic GroupMaximum Observed Concentration (Cmax)560.2 µmol/LStandard Deviation 152.75
Primary

Terminal Half-life

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Renal GroupTerminal Half-life10.16 hoursStandard Deviation 9.32
Healthy VolunteersTerminal Half-life8.51 hoursStandard Deviation 4.57
Hepatic GroupTerminal Half-life5.58 hoursStandard Deviation 2.31
Primary

Time to Maximum Concentration

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Renal GroupTime to Maximum Concentration17.5 hoursStandard Deviation 2.95
Healthy VolunteersTime to Maximum Concentration16.8 hoursStandard Deviation 8.16
Hepatic GroupTime to Maximum Concentration14.2 hoursStandard Deviation 5
Secondary

Urinary Sulfate Concentration

Time frame: pre-dose to 6 days post-dose

ArmMeasureGroupValue (MEAN)Dispersion
Renal GroupUrinary Sulfate ConcentrationDay 3135.53 mg/dLStandard Deviation 86.28
Renal GroupUrinary Sulfate ConcentrationPre-dose 191.58 mg/dLStandard Deviation 40.12
Renal GroupUrinary Sulfate ConcentrationDay 696.98 mg/dLStandard Deviation 47.61
Healthy VolunteersUrinary Sulfate ConcentrationDay 3145.62 mg/dLStandard Deviation 111.02
Healthy VolunteersUrinary Sulfate ConcentrationPre-dose 1131.20 mg/dLStandard Deviation 46.98
Healthy VolunteersUrinary Sulfate ConcentrationDay 6134.65 mg/dLStandard Deviation 74.72
Hepatic GroupUrinary Sulfate ConcentrationPre-dose 186.92 mg/dLStandard Deviation 50.09
Hepatic GroupUrinary Sulfate ConcentrationDay 670.82 mg/dLStandard Deviation 83.64
Hepatic GroupUrinary Sulfate ConcentrationDay 389.83 mg/dLStandard Deviation 67.81

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026