HypercholesterolemiaNCT06556745
Pharmacokinetics of Butyrate Tablet BKR-017
An observational study of Hypercholesterolemia, run by BioKier Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- BKR-017
- Type of treatment
- Pill or oral medicine
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 4 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Healthy subjects on statin therapy between the ages of 18 and 70, inclusive.
Who may be able to join
- Men and women, ages 18-70 inclusive
- Subjects currently on statin treatments.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy
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.
Read the 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.
- Conditions
- Hypercholesterolemia
- Being tested
- BKR-017
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKR-017Drug
Also called butyrate
BKR-017 is an oral tablet formulation designed to target delivery of sodium butyrate to the colon via colon-targeting technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of butyrate
Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing.
Measured: 8 days
Area under the plasma concentration versus time curve (AUC)
AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma.
Measured: 8 days
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure
An assessment of safety will be made using blood pressure at screening, after single dose, and after 7 days repeat dosing.
Measured: 8 days
Incidence of Treatment-Emergent Adverse Events as assessed by heart rate
An assessment of safety will be made using heart rate at screening, after single dose, and after 7 days repeat dosing.
Measured: 8 days
Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel
Hematology (CBC) will be performed at screening, after single dose, and after 7 days repeat dosing.
Measured: 8 days
Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters
An assessment of chemistry laboratory safety parameters will be performed at screening, after single dose, and after 7 days repeat dosing.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start16 Jul 2025
- Primary completion6 May 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioKier Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556745
- Sponsor's protocol ID
- CL-901
- Other IDs
- 1R43HL174321-01A1
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy
- ClinicalTrials.gov ID
- NCT06556745
- Acronym / sponsor ID
- CL-901
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BioKier Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects on statin therapy between the ages of 18 and 70, inclusive.
Key inclusion criteria (2 listed)
- Men and women, ages 18-70 inclusive
- Subjects currently on statin treatments.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKR-017Also: butyrateBKR-017 is an oral tablet formulation designed to target delivery of sodium butyrate to the colon via colon-targeting technology. | Drug | – |
Primary outcome
Peak Plasma Concentration (Cmax) of butyrate
Time frame: 8 days
Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing.
Area under the plasma concentration versus time curve (AUC)
Time frame: 8 days
AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma.
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure
Time frame: 8 days
Incidence of Treatment-Emergent Adverse Events as assessed by heart rate
Time frame: 8 days
Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel
Time frame: 8 days
Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by BioKier Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of butyrate (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.