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RECRUITINGOBSERVATIONAL

Pharmacokinetics of Butyrate Tablet BKR-017

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Men and women, ages 18-70 inclusive - Subjects currently on statin treatments. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BKR-017

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

Locations (1)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States