Pharmacokinetics of Butyrate Tablet BKR-017

Completed

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT06556745

Run by

BioKier Inc.

People needed

9

Starts

2025-07-16

Expected to finish

2026-06-04

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, ages 18-70 inclusive
• Subjects currently on statin treatments.

You may not qualify if…

• 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.

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.