Pharmacokinetics of Butyrate Tablet BKR-017
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT06556745
- Lead Sponsor
- BioKier Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Men and women, ages 18-70 inclusive<br><br> - Subjects currently on statin treatments.<br><br>Exclusion Criteria:<br><br> - Presence of cirrhosis, or other causes of liver disease<br><br> - Substantial alcohol consumption (>20 g/day for women or >30 g/day for men)<br><br> - History of bariatric or intestinal surgery<br><br> - Active gastrointestinal disease including but not limited to irritable bowel<br> syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis),<br> diverticulitis, gastroparesis.<br><br> - Active and clinically significant pancreatic disease, or renal disease as determined<br> by the investigator.<br><br> - History of heart disease that in the opinion of the investigator should exclude the<br> subject from the study.<br><br> - Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant<br> thyroid disease<br><br> - Active significant infection as determined by the investigator.<br><br> - Known allergy to butyrate or any of the components of the tablets.<br><br> - Participation in a clinical trial and/or Dosing with an investigational drug during<br> the 30 days before screening, or within 5 half-lives of receipt of an<br> investigational drug or twice the duration of the biological effect of any<br> investigational drug (whichever is longer)<br><br> - Pregnant, nursing, or trying to become pregnant.<br><br> - In the investigator's judgment, the subject is not suitable for the study for any<br> other reason or cannot commit to the requirements of the study.<br><br> - Subject is taking one or more of the excluded therapies or =4 drugs in total.<br><br> - Taking part in another clinical trial or being in the exclusion period of a previous<br> clinical trial.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of butyrate;Area under the plasma concentration versus time curve (AUC)
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure;Incidence of Treatment-Emergent Adverse Events as assessed by heart rate;Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel;Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters