Clinical trial NCT06556745: Pharmacokinetics of Butyrate Tablet BKR-017
Official title: A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypercholesterolemia
Lead sponsor: BioKier Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects on statin therapy between the ages of 18 and 70, inclusive.

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.

Detailed description: BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic (\>100 mg/dL) statin-treated subjects (to reflect the target population), aged 18-70, after a single dose and at steady-state after seven days repeat dosing. On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of butyrate
timeFrame: 8 days
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 8 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure
timeFrame: 8 days
measure: Incidence of Treatment-Emergent Adverse Events as assessed by heart rate
timeFrame: 8 days
measure: Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel
timeFrame: 8 days
measure: Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters
timeFrame: 8 days
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References: