Pharmacokinetics of Butyrate Tablet BKR-017

A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: BKR-017

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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects on statin therapy between the ages of 18 and 70, inclusive.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioKier Inc.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Frank Greenway, MD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Actual): December 23, 2025
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Butyrates
• Other Study ID Numbers: CL-901; 1R43HL174321-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No