Pharmacokinetics of Butyrate Tablet BKR-017 (NCT06556745) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetics of Butyrate Tablet BKR-017
United States9 participantsStarted 2025-07-16
Plain-language 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 twice daily dosing.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Men and women, ages 18-70 inclusive
* Subjects currently on statin treatments.
Exclusion Criteria:
* 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 …
What they're measuring
1
Peak Plasma Concentration (Cmax) of butyrate
Timeframe: 8 days
2
Area under the plasma concentration versus time curve (AUC)