Status:
RECRUITING
Pharmacokinetics of Butyrate Tablet BKR-017
Lead Sponsor:
BioKier Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Brief Summary
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...
Detailed Description
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-...
Eligibility Criteria
Inclusion
- Men and women, ages 18-70 inclusive
- Subjects currently on statin treatments.
Exclusion
- Presence of cirrhosis, or other causes of liver disease
- Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men)
- History of bariatric or intestinal surgery
- Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis.
- Active and clinically significant pancreatic disease, or renal disease as determined by the investigator.
- History of heart disease that in the opinion of the investigator should exclude the subject from the study.
- Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
- Active significant infection as determined by the investigator.
- Known allergy to butyrate or any of the components of the tablets.
- Participation in a clinical trial and/or Dosing with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
- Pregnant, nursing, or trying to become pregnant.
- In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
Key Trial Info
Start Date :
July 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06556745
Start Date
July 16 2025
End Date
December 30 2025
Last Update
October 6 2025
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808