Pharmacokinetics of Butyrate Tablet BKR-017

NCT06556745 | Recruiting

• 2 other identifiers: CL-9011R43HL174321-01A1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure

  8 days

• Incidence of Treatment-Emergent Adverse Events as assessed by heart rate

  8 days

• Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel

  8 days

• Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters

  8 days

Interventions

BKR-017 DRUG

BKR-017 is an oral tablet formulation designed to target delivery of sodium butyrate to the colon via colon-targeting technology.

Also known as: butyrate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• BioKier Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken at regular intervals for the analysis of butyrate.

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Frank Greenway, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger D Nolan, PhD

CONTACT

919-270-2361; roger.nolan@biokier.com

Jerzy Szewczyk, PhD

CONTACT

919-323-6497; george.szewczyk@biokier.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: August 16, 2024
• Study Start: July 16, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)