RECRUITING

Pharmacokinetics of Butyrate Tablet BKR-017

Description

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

Study Details

Study overview

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.

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

Pharmacokinetics of Butyrate Tablet BKR-017

Condition
Hypercholesterolemia
Intervention / Treatment

-

Contacts and Locations

Baton Rouge

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioKier Inc.,

Frank Greenway, MD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center

Study Record Dates

2025-09