Pharmacokinetics of Butyrate Tablet BKR-017

Recruiting

• Conditions: Hypercholesterolemia

• Registration Number: NCT06556745
• Lead Sponsor: BioKier Inc.

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 twice daily dosing.

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 18-70, after a single dose and at steady-state after seven days repeat dosing. On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed.

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-16
• Status Verified: 2025-07
• Study Start: 2025-07-16
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-08
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 of a previous clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of butyrate	8 days	Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing.
Area under the plasma concentration versus time curve (AUC)	8 days	AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure	8 days	An assessment of safety will be made using blood pressure at screening, after single dose, and after 7 days repeat dosing.
Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel	8 days	Hematology (CBC) will be performed at screening, after single dose, and after 7 days repeat dosing.
Incidence of Treatment-Emergent Adverse Events as assessed by heart rate	8 days	An assessment of safety will be made using heart rate at screening, after single dose, and after 7 days repeat dosing.
Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters	8 days	An assessment of chemistry laboratory safety parameters will be performed at screening, after single dose, and after 7 days repeat dosing.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States