Chronic Heart FailurePhase 1NCT05102266
A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016C" With "BR1016D" in Healthy Volunteers
A Phase 1 study testing BR1016C and BR1016D in people with Chronic Heart Failure, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
To evaluate the pharmacokinetic properties and safety of "BR1016C" and "BR1016D" in healthy adults. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- BR1016C and BR1016D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2021to 18 Dec 2021
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 19 years or older at screening
- Individuals with an index BMI of 18.0 to 30.0 for obesity (BMI calculation: weight (kg)/height (m)2)
- Males weighing 50 kg or more
- Females weighing 45 kg or more
- Those who do not have clinically significant congenital or chronic diseases and do not have pathological symptoms or findings as a result of medical examination (electroencephalography, electrocardiogram, chest and stomach endoscopy or gastrointestinal radiography, if necessary)
- A person who has been determined by the principal investigator (or a delegated sub-investigator) to be eligible as a subject based on the results of electrocardiography (ECG) and clinical laboratory tests such as hematology, blood chemistry, serology, urinalysis, etc. conducted according to the properties of the drug
- Those who voluntarily decided to participate in the study after being given a detailed explanation of this clinical trial and understanding it fully, and provided a written consent to follow the precautions during the clinical study period
- Those who agreed to rule out the possibility of a pregnancy by using a medically accepted method of contraception* for themselves, their spouse, or their partner from the date of screening until 7 days after the date of the last investigational product administration and agreed not to provide sperm or eggs *Medically acceptable methods of contraception: Combined use of intrauterine device (IUD, IUS), vasectomy, tubal ligation and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
Who cannot join
- Those who have taken drugs that induce and inhibit drug metabolizing enzymes such as barbitals within 30 days prior to the initiation of the study (date of first administration) or who have taken drugs that may interfere with this study within 10 days prior to the initiation of the study (date of first administration)
- Those who have participated in a bioequivalence study or other clinical study within 180 days prior to the initiation of the study (date of first administration) and have received the investigational product
- Those who have donated whole blood or blood within 60 days prior to the first day of administration, or donated blood components within 14 days prior to the first day of administration or who have received a blood transfusion within 30 days
- Those who have gastrointestinal disease or history of gastrointestinal resection (except for hernia surgery or simple appendectomy) that may affect the absorption of the drug
- Those who have continued drinking alcohol within 30 days prior to the initiation of the study (date of first administration)
- Male: 4 drinks/time, more than 14 drinks/week
Show all 31Show fewer
- Female: 3 drinks/time, more than 7 drinks/week (1 drink: 45 mL of spirits, 150 mL of wine, 350-360 mL of beer, 300 mL of makgeolli, 90 mL of 20% soju)
- Smokers who smoked more than 10 cigarettes a day within the 90 days prior to the initiation of the study (date of first administration) and who are unable to stop smoking from 48 hours prior to the first administration of the investigational product until the last blood collection
- Those who have ingested or cannot refrain from ingesting caffeine-containing foods (e.g., coffee, green tea, tea, soda, coffee milk, sour tonic drinks, etc.) from 48 hours prior to the initiation of the study (date of first administration) until the last blood collection
- Those who have had an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug (e.g., consumption of grapefruit juice (at least 1L per day) within 7 days prior to administration of the investigational product)
- Those who meet any of the criteria below in the clinical laboratory test results at screening
- AST (SGOT) or ALT (SGPT) or γ-GTP levels in blood greater than 1.5 times the upper limit of the normal range (ULN)
- eGFR < 60mL/min/1.73 m2
- Sodium(Na) < 135 mEq/l
- Potassium(K) > 5.0 mEq/l
- Positive results in HBsAg, HCV-Ab, HIV antibody, and VDRL (Syphilis/qualitative) test
- Those who meet any of the criteria below in the results of vital sign measurement at screening
- Systolic blood pressure: Less than 90 mmHg or more than 139 mmHg
- Diastolic blood pressure: Less than 60 mmHg or more than 90 mmHg
- Pulse rate: Greater than 100/min
- Patients with the following conditions
- Those who have a hypersensitivity reaction to the active ingredient of this drug or to any component of this drug
- Those who are receiving an angiotensin-converting enzyme (ACE) inhibitor or have not passed 36 hours after discontinuing the administration
- Those who have a history of angioedema when angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor antagonist (ARB) was administered
- Those with hereditary or idiopathic angioedema
- Severe hepatic impairment, cirrhosis or biliary obstruction, cholestasis
- Those who are receiving a combination administration with aliskiren for diabetes or moderate to severe renal impairment (eGFR < 60mL/min/1.73 m2)
- Those with primary hyperaldosteronism
- Those with a history of clinically significant psychiatric illness within 5 years prior to the screening visit
- For female volunteers, pregnant women or those who may be pregnant or are breastfeeding
- Individuals who the principal investigator (or a delegated sub-investigator) has determined to be ineligible for this clinical study for reasons other than the inclusion/exclusion criteria described above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and Safety of "BR1016C" With "BR1016D" in Healthy Volunteers
To evaluate the pharmacokinetic properties and safety of "BR1016C" and "BR1016D" in healthy adults.
Read the detailed description
Descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.) will be presented for continuous data, and the number (N) and percentage (%) of subjects for each category will be summarized and presented for categorical data. For pharmacokinetic data, the number of subjects, mean, standard deviation, coefficient of variation (primary endpoint only), median, minimum, and maximum will be presented by treatment group.
<Demographic information statistical analysis>
- Descriptive statistical analysis will be performed on basic data including demographic information (gender, age, height, weight, BMI, etc.) of all randomized subjects (Intention-To-Treat).
- Continuous data will be compared and tested between sequence groups by summarizing descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.), and by testing whether the data are normally distributed using the independent t-test or Wilcoxon's rank sum test. For categorical data, the number (N) and percentage (%) of subjects for each category will be summarized and compared between the order groups using a Chi-square test or Fisher's exact test.
<Pharmacokinetic statistical analysis>
- The pharmacokinetic assessment will be analyzed in subjects who can complete all scheduled blood sampling for pharmacokinetic assessment after administration of the investigational product according to the protocol and can be assessed for pharmacokinetics, and there are no major protocol violations that may affect the pharmacokinetic analysis.
- The pharmacokinetic assessment will be conducted in accordance with Article 17 of the "Drug Equivalence Test Criteria" and the pharmacokinetic parameters will be calculated using a noncompartmental method using the software 'Phoenix® Winnonlin® Ver.8.3 (or higher) (Certara L.P.)'. When calculating pharmacokinetic parameters, the actual sampling time will be used for the sampling time for each subject, and the linear trapezoidal method will be used for the calculation of AUCt. Pharmacokinetic parameters will be summarized and presented descriptively by subject and treatment group. For statistical analysis for equivalence assessment, analysis of variance will be performed for log-transformed values of AUCt and Cmax at a significance level of 0.05. If the 90% confidence interval of the difference between the control drug and the mean value of the study drug is within log 0.8 to log 1.25, the control drug and the study drug will be assessed as equivalent. Descriptive statistics will be presented by treatment group, and they will be compared between treatment groups if necessary.
- The analysis of variance will test the administration period (period), sequence group (sequence), and treatment group (treatment) as fixed effects, and the difference between individuals as linear mixed effect model considering random effects.
<Safety statistical analysis>
- The analysis set for safety assessment includes all subjects who received the investigational product at least once.
- Adverse events will be assessed based on the treatment-emergent adverse events (TEAEs) that occur after the administration of the investigational product in Period 1. For TEAEs that occurred during the washout period, hospital admission date, and prior to administration, it will be determined as a TEAE of the investigational product that was administered previously.
Adverse event names will be standardized by SOC (System Organ Class) and PT (Preferred Term) terms using the MedDRA (version 24.0 or higher) classification system, and the analysis of adverse events will be presented as the number of subjects who experienced adverse events, incidence (%), and number of occurrences based on TEAEs. The severity, seriousness, and causal relationship to the investigational product of adverse events will be summarized by treatment group. If necessary, the Chi-square test, Fisher's exact test or McNemar's test will be conducted to test for inter-group differences.
- The names of concomitant medications will be standardized using the WHO ATC (2021 or later) classification system, and subjects who received concomitant medications during the clinical study will be listed. In case of concomitant medications taken during the washout period, hospital admission date, or before the administration, it shall be determined as the concomitant medication of the investigational product that was administered previously.
- For other observation and test items of the subjects such as clinical laboratory tests, vital signs, electrocardiography (ECG), and physical examinations, descriptive statistical analysis will be performed.
- Conditions
- Chronic Heart Failure
- Being tested
- BR1016C, BR1016D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1016CDrug
Also called Study drug
All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
BR1016DDrug
Also called Reference drug
All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
| Study group | Role | What they receive |
|---|---|---|
| A(RT) | Experimental | Reference drug "BR1016D" 1 tablet is administered once in fasted state. After having a break of 7 days or more, study drug "BR1016C" 1 tablet is administered once in fasted state. Receives: Drug: BR1016C; Drug: BR1016D |
| B(TR) | Experimental | Study drug "BR1016C" 1 tablet is administered once in fasted state. After having a break of 7 days or more, reference drug "BR1016D" 1 tablet is administered once in fasted state. Receives: Drug: BR1016C; Drug: BR1016D |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of BR1016C and BR1016D
Area under the plasma drug concentration-time curve of BR1016C and BR1016D
Measured: 0-36 hours after administration
Cmax of BR1016C and BR1016D
Maximum concentration of drug in plasma of BR1016C and BR1016D
Measured: 0-36 hours after administration
Secondary outcomes (1)
AUC∞, AUCt/AUC∞, Tmax, t1/2, CL/F and Vz/F of BR1016C and BR1016D
AUC∞, AUCt/AUC∞, Tmax, t1/2, CL/F and Vz/F of BR1016C and BR1016D
Measured: 0-36 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start27 Oct 2021
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Min Seong, Principal investigator, Bestian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102266
- Sponsor's protocol ID
- BR-SVMC-CT-102
- Status last verified
- May 2023
- First submitted
- 20 Oct 2021
- Last updated
- 24 May 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and Safety of "BR1016C" With "BR1016D" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05102266
- Acronym / sponsor ID
- BR-SVMC-CT-102
- Conditions
- Chronic Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 1 Nov 2021 (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.
To evaluate the pharmacokinetic properties and safety of "BR1016C" and "BR1016D" in healthy adults.
Detailed description
Descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.) will be presented for continuous data, and the number (N) and percentage (%) of subjects for each category will be summarized and presented for categorical data. For pharmacokinetic data, the number of subjects, mean, standard deviation, coefficient of variation (primary endpoint only), median, minimum, and maximum will be presented by treatment group.
<Demographic information statistical analysis>
- Descriptive statistical analysis will be performed on basic data including demographic information (gender, age, height, weight, BMI, etc.) of all randomized subjects (Intention-To-Treat).
- Continuous data will be compared and tested between sequence groups by summarizing descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum, etc.), and by testing whether the data are normally distributed using the independent t-test or Wilcoxon's rank sum test. For categorical data, the number (N) and percentage (%) of subjects for each category will be summarized and compared between the order groups using a Chi-square test or Fisher's exact test.
<Pharmacokinetic statistical analysis>
- The pharmacokinetic assessment will be analyzed in subjects who can complete all scheduled blood sampling for pharmacokinetic assessment after administration of the investigational product according to the protocol and can be assessed for pharmacokinetics, and there are no major protocol violations that may affect the pharmacokinetic analysis.
- The pharmacokinetic assessment will be conducted in accordance with Article 17 of the "Drug Equivalence Test Criteria" and the pharmacokinetic parameters will be calculated using a noncompartmental method using the software 'Phoenix® Winnonlin® Ver.8.3 (or higher) (Certara L.P.)'. When calculating pharmacokinetic parameters, the actual sampling time will be used for the sampling time for each subject, and the linear trapezoidal method will be used for the calculation of AUCt. Pharmacokinetic parameters will be summarized and presented descriptively by subject and treatment group. For statistical analysis for equivalence assessment, analysis of variance will be performed for log-transformed values of AUCt and Cmax at a significance level of 0.05. If the 90% confidence interval of the difference between the control drug and the mean value of the study drug is within log 0.8 to log 1.25, the control drug and the study drug will be assessed as equivalent. Descriptive statistics will be presented by treatment group, and they will be compared between treatment groups if necessary.
- The analysis of variance will test the administration period (period), sequence group (sequence), and treatment group (treatment) as fixed effects, and the difference between individuals as linear mixed effect model considering random effects.
<Safety statistical analysis>
- The analysis set for safety assessment includes all subjects who received the investigational product at least once.
- Adverse events will be assessed based on the treatment-emergent adverse events (TEAEs) that occur after the administration of the investigational product in Period 1. For TEAEs that occurred during the washout period, hospital admission date, and prior to administration, it will be determined as a TEAE of the investigational product that was administered previously.
Adverse event names will be standardized by SOC (System Organ Class) and PT (Preferred Term) terms using the MedDRA (version 24.0 or higher) classification system, and the analysis of adverse events will be presented as the number of subjects who experienced adverse events, incidence (%), and number of occurrences based on TEAEs. The severity, seriousness, and causal relationship to the investigational product of adverse events will be summarized by treatment group. If necessary, the Chi-square test, Fisher's exact test or McNemar's test will be conducted to test for inter-group differences.
- The names of concomitant medications will be standardized using the WHO ATC (2021 or later) classification system, and subjects who received concomitant medications during the clinical study will be listed. In case of concomitant medications taken during the washout period, hospital admission date, or before the administration, it shall be determined as the concomitant medication of the investigational product that was administered previously.
- For other observation and test items of the subjects such as clinical laboratory tests, vital signs, electrocardiography (ECG), and physical examinations, descriptive statistical analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(RT) | Experimental | Drug: BR1016C, Drug: BR1016DReference drug "BR1016D" 1 tablet is administered once in fasted state. After having a break of 7 days or more, study drug "BR1016C" 1 tablet is administered once in fasted state. |
| B(TR) | Experimental | Drug: BR1016C, Drug: BR1016DStudy drug "BR1016C" 1 tablet is administered once in fasted state. After having a break of 7 days or more, reference drug "BR1016D" 1 tablet is administered once in fasted state. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals aged 19 years or older at screening
- Individuals with an index BMI of 18.0 to 30.0 for obesity (BMI calculation: weight (kg)/height (m)2)
- Those who do not have clinically significant congenital or chronic diseases and do not have pathological symptoms or findings as a result of medical examination (electroencephalography, electrocardiogram, chest and stomach endoscopy or gastrointestinal radiography, if necessary)
- A person who has been determined by the principal investigator (or a delegated sub-investigator) to be eligible as a subject based on the results of electrocardiography (ECG) and clinical laboratory tests such as hematology, blood chemistry, serology, urinalysis, etc. conducted according to the properties of the drug
- Those who voluntarily decided to participate in the study after being given a detailed explanation of this clinical trial and understanding it fully, and provided a written consent to follow the precautions during the clinical study period
Key exclusion criteria (31 listed)
- Those who have taken drugs that induce and inhibit drug metabolizing enzymes such as barbitals within 30 days prior to the initiation of the study (date of first administration) or who have taken drugs that may interfere with this study within 10 days prior to the initiation of the study (date of first administration)
- Those who have participated in a bioequivalence study or other clinical study within 180 days prior to the initiation of the study (date of first administration) and have received the investigational product
- Those who have donated whole blood or blood within 60 days prior to the first day of administration, or donated blood components within 14 days prior to the first day of administration or who have received a blood transfusion within 30 days
- Those who have gastrointestinal disease or history of gastrointestinal resection (except for hernia surgery or simple appendectomy) that may affect the absorption of the drug
- Those who have continued drinking alcohol within 30 days prior to the initiation of the study (date of first administration)
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 |
|---|---|---|
| BR1016CAlso: Study drugAll subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period. | Drug | A(RT), B(TR) |
| BR1016DAlso: Reference drugAll subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period. | Drug | A(RT), B(TR) |
Primary outcome
AUCt of BR1016C and BR1016D
Time frame: 0-36 hours after administration
Area under the plasma drug concentration-time curve of BR1016C and BR1016D
Cmax of BR1016C and BR1016D
Time frame: 0-36 hours after administration
Maximum concentration of drug in plasma of BR1016C and BR1016D
1 secondary outcome
AUC∞, AUCt/AUC∞, Tmax, t1/2, CL/F and Vz/F of BR1016C and BR1016D
Time frame: 0-36 hours after administration
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 24 May 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.
Chang-Min Seong principal investigator
Bestian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR1016C and BR1016D in people with Chronic Heart Failure, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
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 8 inclusion and 31 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 24 May 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 South Korea. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
AUCt of BR1016C and BR1016D (time frame: 0-36 hours after administration). 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 24 May 2023.