NCT06556745Completed
Pharmacokinetics of Butyrate Tablet BKR-017
A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 9 (actual)
- First submitted
- 14 Jun 2024
- Start date
- 16 Jul 2025
- Primary completion date
- 6 May 2026
- Lead sponsor
- BioKier Inc.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06556745
What you commit to
- Study type: Observational
- Participants enrolled: 9
- From 16 Jul 2025 to the primary completion date, 6 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
Other illness
- Presence of cirrhosis, or other causes of liver disease
- 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.
Other
- Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men)
- 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.
Who the study is looking for
- Men and women, ages 18-70 inclusive
- Subjects currently on statin treatments.
Age in the registry: 18 years to 70 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.