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