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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43HL174321-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing.
BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic (>100 mg/dL) statin-treated subjects (to reflect the target population), aged 18-70, after a single dose and at steady-state after seven days repeat dosing. On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKR-017 | Drug | BKR-017 is an oral tablet formulation designed to target delivery of sodium butyrate to the colon via colon-targeting technology. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of butyrate | Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing. | 8 days |
| Area under the plasma concentration versus time curve (AUC) | AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure | An assessment of safety will be made using blood pressure at screening, after single dose, and after 7 days repeat dosing. | 8 days |
| Incidence of Treatment-Emergent Adverse Events as assessed by heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects on statin therapy between the ages of 18 and 70, inclusive.
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| Name | Affiliation | Role |
|---|---|---|
| Frank Greenway, MD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2024 | Aug 12, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002087 | Butyrates |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
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Blood samples will be taken at regular intervals for the analysis of butyrate.
An assessment of safety will be made using heart rate at screening, after single dose, and after 7 days repeat dosing. |
| 8 days |
| Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel | Hematology (CBC) will be performed at screening, after single dose, and after 7 days repeat dosing. | 8 days |
| Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters | An assessment of chemistry laboratory safety parameters will be performed at screening, after single dose, and after 7 days repeat dosing. | 8 days |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |