RECRUITING

Pharmacokinetics of Butyrate Tablet BKR-017

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-16

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06556745

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Roger D Nolan, PhD

CONTACT

919-270-2361

roger.nolan@biokier.com

Jerzy Szewczyk, PhD

CONTACT

919-323-6497

george.szewczyk@biokier.com

Principal Investigator

Frank Greenway, MD

PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Study Locations (Sites)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808

United States

Collaborators and Investigators

Sponsor: BioKier Inc.

Frank Greenway, MD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16

Study Completion Date2025-09

Study Record Updates

Study Start Date2025-07-16

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Hypercholesterolemia