PharmacokineticsNCT05686083
Pharmacokinetics of Two Fatty Acid Ketone Esters
A study testing C6 ketone di-ester and Novel ketone di-ester in people with Pharmacokinetics, run by BHB Therapeutics, Ireland LTD at 1 site in United States.
Trial summary
Randomized, cross over pharmacokinetic study of a novel ketone di-ester and C6 ketone di-ester in ready to drink beverage matrices. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- C6 ketone di-ester and Novel ketone di-ester
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 31 Mar 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has a BMI 18.5-34.99 kg/m2 (inclusive)
- Subject is not a smoker and has no plans to change his/her usage of the following products throughout the study period: tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches)
- Subject is a non-user or former user (cessation ≥3 months) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period. No washout is required for topical marijuana or hemp products, but subjects are required to abstain from these products during the study period.
- Subject is willing and able to comply with all study procedures including overnight fasting (12 ± 2 h, water only), maintenance of usual body weight, avoidance of foods or supplements that increase ketone production in the body throughout the entire study period, avoidance of vigorous exercise (moderate habitual exercise is allowed) with the exception of the 24 h prior to Visits 2, 3, and 4 (Days 0, 7, and 14) when subjects must avoid exercise completely
- Subjects is willing to abstain from caffeine during Visits 2 and 3 (Days 0 and 7).
- Subject has a score of 7 to 10 on the Vein Access Scale
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- Subject is willing and able to comply with the visit schedule.
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history, physical examination findings, and routine laboratory test results.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages and all other foods/beverages provided in this study, including soy, and milk.
- Subject has extreme dietary habits (e.g., intermittent fasting or time restricted eating, Atkins diet, vegan, very high protein/low carbohydrate within 30 days of Visit 1 (Day -7).
- Subject has used weight-loss medications (including over-the-counter medications and/or supplements) or participated in weight loss programs within 30 days of Visit 1 (Day -7).
- Unstable use of any prescription medications is not allowed. Prescription medications must be kept at a stable dose (defined as same dose for the past 30 days prior to Visit 1, Day -7).
- Subject has used ketone supplements (ketone salts or esters, and medium chain triglycerides [MCT]) within 30 days of Visit 1 (Day -7).
- Subject has been exposed to any non-registered drug product within 30 days of Visit 1 (Day -7).
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- Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type 1 or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, gastrointestinal, hematologic, immunologic, dermatologic, rheumatic (including gout), and/or biliary condition(s), that, in the opinion of the Clinical Investigator (has MD qualifications), could interfere with the interpretation of the study results.
- Subject has a history of bariatric surgery for weight reducing purposes.
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Subject has an abnormal laboratory test result(s) of clinical importance at Visit 1 (Day -7), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal laboratory test results.
- Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days of Visit 2 (Day 0). If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 days prior to testing.
- Subject has experienced any major trauma or any other surgical event within three months of Visit 1 (Day -7).
- Subject has had a loss of 400 mL of blood (e.g., blood/plasma donation) within 30 days of Visit 2 (Day 0).
- Subject has recently (within 6 months of Visit 1; Day -7) had a weight loss or gain >4.5 kg.
- Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7). One re-test will be allowed on a separate day before Visit 2 (Day 0), for subjects with abnormal blood pressure at the discretion of the Clinical Investigator.
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
- Subject has a recent history of (within 12 months of screening; Visit 1; Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Individual has a condition the Clinical Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Crossover Study to Assess the Pharmacokinetics of a Novel Ketone Di-ester in Healthy Adults
Randomized, cross over pharmacokinetic study of a novel ketone di-ester and C6 ketone di-ester in ready to drink beverage matrices.
Read the detailed description
Recruiting 12 healthy adults to participate in a pharmacokinetic (PK) study of a novel ketone di-ester and C6 ketone di-ester in ready to drink beverage matrices. Following randomization, subjects will participate in three full days of PK sample collection. Blood samples will be collected for 8 hours following test product consumption on all PK days.
- Conditions
- Pharmacokinetics
- Being tested
- C6 ketone di-ester, Novel ketone di-ester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C6 ketone di-esterDietary supplement
C6 ketone di-ester
Novel ketone di-esterDietary supplement
Novel ketone di-ester
| Study group | Role | What they receive |
|---|---|---|
| 12.5 g of C6 ketone di-ester | Active comparator | Low dose of C6 ketone di-ester. Receives: Dietary Supplement: C6 ketone di-ester |
| 12.5 g of novel ketone di-ester | Active comparator | Low dose of novel ketone di-ester. Receives: Dietary Supplement: Novel ketone di-ester |
| 25 g of novel ketone di-ester | Active comparator | High dose of novel ketone di-ester. Receives: Dietary Supplement: Novel ketone di-ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
AUC of circulating metabolites in blood
Measured: 0 - 8 hours
Cmax
Maximum concentration of circulating metabolites in blood
Measured: 0 - 8 hours
Tmax
Time to maximum concentration of circulating metabolites in blood
Measured: 0 - 8 hours
Elimination half-life
Time required to reduce metabolite concentration by 50%
Measured: 0 - 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start30 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three way crossover in a random order
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- BHB Therapeutics, Ireland LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis, Merieux NutriSciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686083
- Sponsor's protocol ID
- BIO2302
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 20 Apr 2023
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Study to Assess the Pharmacokinetics of a Novel Ketone Di-ester in Healthy Adults
- ClinicalTrials.gov ID
- NCT05686083
- Acronym / sponsor ID
- BIO2302
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BHB Therapeutics, Ireland LTDIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis, Merieux NutriSciences
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Jan 2023 (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.
Randomized, cross over pharmacokinetic study of a novel ketone di-ester and C6 ketone di-ester in ready to drink beverage matrices.
Detailed description
Recruiting 12 healthy adults to participate in a pharmacokinetic (PK) study of a novel ketone di-ester and C6 ketone di-ester in ready to drink beverage matrices. Following randomization, subjects will participate in three full days of PK sample collection. Blood samples will be collected for 8 hours following test product consumption on all PK days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three way crossover in a random order
| Arm | Type | Receives |
|---|---|---|
| 12.5 g of C6 ketone di-ester | Active comparator | Dietary Supplement: C6 ketone di-esterLow dose of C6 ketone di-ester. |
| 12.5 g of novel ketone di-ester | Active comparator | Dietary Supplement: Novel ketone di-esterLow dose of novel ketone di-ester. |
| 25 g of novel ketone di-ester | Active comparator | Dietary Supplement: Novel ketone di-esterHigh dose of novel ketone di-ester. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has a BMI 18.5-34.99 kg/m2 (inclusive)
- Subject is not a smoker and has no plans to change his/her usage of the following products throughout the study period: tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches)
- Subject is a non-user or former user (cessation ≥3 months) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period. No washout is required for topical marijuana or hemp products, but subjects are required to abstain from these products during the study period.
- Subject is willing and able to comply with all study procedures including overnight fasting (12 ± 2 h, water only), maintenance of usual body weight, avoidance of foods or supplements that increase ketone production in the body throughout the entire study period, avoidance of vigorous exercise (moderate habitual exercise is allowed) with the exception of the 24 h prior to Visits 2, 3, and 4 (Days 0, 7, and 14) when subjects must avoid exercise completely
- Subjects is willing to abstain from caffeine during Visits 2 and 3 (Days 0 and 7).
Key exclusion criteria (18 listed)
- Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages and all other foods/beverages provided in this study, including soy, and milk.
- Subject has extreme dietary habits (e.g., intermittent fasting or time restricted eating, Atkins diet, vegan, very high protein/low carbohydrate within 30 days of Visit 1 (Day -7).
- Subject has used weight-loss medications (including over-the-counter medications and/or supplements) or participated in weight loss programs within 30 days of Visit 1 (Day -7).
- Unstable use of any prescription medications is not allowed. Prescription medications must be kept at a stable dose (defined as same dose for the past 30 days prior to Visit 1, Day -7).
- Subject has used ketone supplements (ketone salts or esters, and medium chain triglycerides [MCT]) within 30 days of Visit 1 (Day -7).
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 |
|---|---|---|
| C6 ketone di-esterC6 ketone di-ester | Dietary supplement | 12.5 g of C6 ketone di-ester |
| Novel ketone di-esterNovel ketone di-ester | Dietary supplement | 12.5 g of novel ketone di-ester, 25 g of novel ketone di-ester |
Primary outcome
Area under the curve (AUC)
Time frame: 0 - 8 hours
AUC of circulating metabolites in blood
Cmax
Time frame: 0 - 8 hours
Maximum concentration of circulating metabolites in blood
Tmax
Time frame: 0 - 8 hours
Time to maximum concentration of circulating metabolites in blood
Elimination half-life
Time frame: 0 - 8 hours
Time required to reduce metabolite concentration by 50%
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 20 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C6 ketone di-ester and Novel ketone di-ester in people with Pharmacokinetics, run by BHB Therapeutics, Ireland LTD 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 9 inclusion and 18 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 20 Apr 2023. 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?
Area under the curve (AUC) (time frame: 0 - 8 hours). The study lists 4 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 20 Apr 2023.