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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Group | Experimental | Patients with moderate renal impairment |
|
| Healthy volunteers | Active Comparator | Healthy volunteers |
|
| Hepatic Group | Experimental | Patients with mild/moderate hepatic impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI-800 | Drug | BLI-800 oral solution (two doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Sulfate Concentration | pre-dose to 6 days post-dose |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell Pelham, Ph.D. | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis | Minnesota | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Group | BLI-800 oral solution in patients with moderate renal impairment |
| FG001 | Healthy Volunteers | BLI-800 oral solution in healthy volunteers |
| FG002 | Hepatic Group | BLI-800 oral solution in patients with mild/moderate hepatic impairment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Group | BLI-800 oral solution in patients with moderate renal impairment |
| BG001 | Healthy Volunteers | BLI-800 oral solution in healthy volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) | Posted | Mean | Standard Deviation | µmol/L | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Renal Group | BLI-800 oral solution in patients with moderate renal impairment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramping | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Pelham, PhD | Braintree Laboratories, Inc. | 781-843-2202 | rpelham@braintreelabs.com |
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| BG002 | Hepatic Group | BLI-800 oral solution in patients with mild/moderate hepatic impairment. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Urinary Sulfate Concentration | Posted | Mean | Standard Deviation | mg/dL | pre-dose to 6 days post-dose |
|
|
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| Primary | Time to Maximum Concentration | Posted | Mean | Standard Deviation | hours | 1 day |
|
|
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| Primary | Terminal Half-life | Posted | Mean | Standard Deviation | hours | 1 day |
|
|
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| Primary | Area Under the Curve for the 24-hour Dosing Interval | Posted | Mean | Standard Deviation | µmol*hr/L | 1 day |
|
|
|
| Primary | Elimination Rate Constant | Posted | Mean | Standard Deviation | 1/hr | 1 day |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Healthy Volunteers | BLI-800 oral solution in healthy volunteers | 0 | 6 | 4 | 6 |
| EG002 | Hepatic Group | BLI-800 oral solution in patients with mild/moderate hepatic impairment. | 0 | 6 | 5 | 6 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Chest congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Perianal irritation | Gastrointestinal disorders | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Abnormal urinalysis | Investigations | Systematic Assessment |
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| Elevated serum creatinine | Investigations | Systematic Assessment |
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| Symptomatic hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
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| Day 6 |
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