Chronic Renal FailurePhase 1NCT04952506
Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers
A Phase 1 study testing CKD-349 F1 Tab., CKD-349 F2 Tab. and D113 Tab. in people with Chronic Renal Failure, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- CKD-349 F1 Tab., CKD-349 F2 Tab. and D113 Tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2021to 20 Aug 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
- Healthy adults over the age of 19 years at the time of screening
- Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9kg/m2 and total body weight ≥ 55 kg
- BMI = Weight(kg)/ Height(m)2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed within 28 days to the scheduled date of first administration of the investigational product
- In case of female subjects, those who were confirmed to be non-pregnant at screening
- Individuals who agreed to the use of appropriate medically recognized contraceptive methods themselves or their spouse (or partner) from the first administration of the investigational product to the 7th day of last administration. And in case of male subjects, those who agreed not donation of sperm, in case of female subjects, those who agreed not to be pregnant or breast-feeding from the first administration of the investigational product to the 7th day of last administration
- Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial.
Who cannot join
- Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
- Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
- Individuals with hypersensitivity to investigational products or the investigational products ingredients
- Angiotensin-converting enzyme(ACE) inhibitors are being administered or less than 36hr after discontinuation.
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- Individuals with history of vascular edema in angiotensin-converting enzyme(ACE) inhibitors or angiotensin receptor blocker(ARB) administration
- Individuals with genetic or idiopathic angioedema
- Individuals with liver cirrhosis or atresia of bile ducts or cholestasis
- Individuals with primary hyperaldosteronism
- Following vital signs results at screening
- Sitting systolic blood pressure > 140 mmHg or < 90 mmHg
- Sitting diastolic blood pressure > 90 mmHg or <60 mmHg
- Individuals with the following results at screening test:
- AST(GOT) or ALT(GPT) > 2x the upper limit of the normal range
- Creatinine > upper limit of the normal range or eGFR with MDRD <60 ml/min/1.73 m2
- K > 5.5mEq/l
- Positive reaction on serum test(PRP Ab, anti HIV(AIDS), HBs Ag, HCV Ab)
- Individuals with a medical history of significant drug abuse or positive for abuse drug in urine test results at screening
- Individuals who had taken ethical(ETC) or over the counter(OTC) within the 10 days prior to the first dose of investigational product
- Individuals who donated whole blood within the 8 weeks, or donated blood components within 4 weeks prior to the first dose of the investigational product or received a blood transfusion with 4 weeks
- Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
- Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 1 month before the first administration of clinical trial drug
- Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to first dose of this study or cannot quit drinking during clinical trials period
- A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml of pure alcohol) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
- Individuals who exceed the smoking amount of 10 cigarettes per day within 3 months prior to first dose of this study or cannot quit smoking during clinical trials period
- Individuals who cannot eat standard meal in institution
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dosing, 3-treatment, 6-sequence, 3-period, Crossover-design Pilot Clinical Trial to Compare the Safety and Pharmacokinetics of D113 With CKD-349 in Healthy Adult Volunteers
This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
Read the detailed description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Chronic Renal Failure
- Being tested
- CKD-349 F1 Tab., CKD-349 F2 Tab., D113 Tab.
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-349 F1 Tab.Drug
Also called Test 1
1T Single does
CKD-349 F2 Tab.Drug
Also called Test 2
1T Single does
D113 Tab.Drug
Also called Reference
1T Single does
| Study group | Role | What they receive |
|---|---|---|
| R-T1-T2 | Experimental | 1. Period 1: Reference
2. Period 2: Test 1
3. Period 3: Test 2 Receives: Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab. |
| T2-R-T1 | Experimental | 1. Period 1: Test 2
2. Period 2: Reference
3. Period 3: Test 1 Receives: Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab. |
| T1-T2-R | Experimental | 1. Period 1: Test 1
2. Period 2: Test 2
3. Period 3: Reference Receives: Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab. |
| T2-T1-R | Experimental | 1. Period 1: Test 2
2. Period 2: Test 1
3. Period 3: Reference Receives: Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab. |
| T1-R-T2 | Experimental | 1. Period 1: Test 1
2. Period 2: Reference
3. Period 3: Test 2 Receives: Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab. |
| R-T2-T1 | Experimental | 1. Period 1: Reference
2. Period 2: Test 2
3. Period 3: Test 1 Receives: Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-349, D113
Area under the CKD-349/D113 concentration in blood-time curve from zero to final
Measured: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-349, D113
The maximum CKD-349/D113 concentration in blood sampling time t
Measured: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start19 Jul 2021
- Primary completion29 Jul 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang Hee Hong, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952506
- Sponsor's protocol ID
- A111_02PK2111P
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2021
- Last updated
- 24 Jan 2024
- Results posted
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dosing, 3-treatment, 6-sequence, 3-period, Crossover-design Pilot Clinical Trial to Compare the Safety and Pharmacokinetics of D113 With CKD-349 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04952506
- Acronym / sponsor ID
- A111_02PK2111P
- Conditions
- Chronic Renal Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 7 Jul 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.
This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
Detailed description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| R-T1-T2 | Experimental | Drug: CKD-349 F1 Tab., Drug: CKD-349 F2 Tab., Drug: D113 Tab.1. Period 1: Reference 2. Period 2: Test 1 3. Period 3: Test 2 |
| T2-R-T1 | Experimental | Drug: CKD-349 F1 Tab., Drug: CKD-349 F2 Tab., Drug: D113 Tab.1. Period 1: Test 2 2. Period 2: Reference 3. Period 3: Test 1 |
| T1-T2-R | Experimental | Drug: CKD-349 F1 Tab., Drug: CKD-349 F2 Tab., Drug: D113 Tab.1. Period 1: Test 1 2. Period 2: Test 2 3. Period 3: Reference |
| T2-T1-R | Experimental | Drug: CKD-349 F1 Tab., Drug: CKD-349 F2 Tab., Drug: D113 Tab.1. Period 1: Test 2 2. Period 2: Test 1 3. Period 3: Reference |
| T1-R-T2 | Experimental | Drug: CKD-349 F1 Tab., Drug: CKD-349 F2 Tab., Drug: D113 Tab.1. Period 1: Test 1 2. Period 2: Reference 3. Period 3: Test 2 |
| R-T2-T1 | Experimental | Drug: CKD-349 F1 Tab., Drug: CKD-349 F2 Tab., Drug: D113 Tab.1. Period 1: Reference 2. Period 2: Test 2 3. Period 3: Test 1 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adults over the age of 19 years at the time of screening
- Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9kg/m2 and total body weight ≥ 55 kg
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed within 28 days to the scheduled date of first administration of the investigational product
- In case of female subjects, those who were confirmed to be non-pregnant at screening
Key exclusion criteria (28 listed)
- Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
- Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
- Following vital signs results at screening
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 |
|---|---|---|
| CKD-349 F1 Tab.Also: Test 11T Single does | Drug | R-T1-T2, R-T2-T1, T1-R-T2, T1-T2-R, T2-R-T1, T2-T1-R |
| CKD-349 F2 Tab.Also: Test 21T Single does | Drug | R-T1-T2, R-T2-T1, T1-R-T2, T1-T2-R, T2-R-T1, T2-T1-R |
| D113 Tab.Also: Reference1T Single does | Drug | R-T1-T2, R-T2-T1, T1-R-T2, T1-T2-R, T2-R-T1, T2-T1-R |
Primary outcome
AUCt of CKD-349, D113
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Area under the CKD-349/D113 concentration in blood-time curve from zero to final
Cmax of CKD-349, D113
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
The maximum CKD-349/D113 concentration in blood sampling time t
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 Jan 2024.
- 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.
Jang Hee Hong principal investigator
Chungnam National University 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 CKD-349 F1 Tab., CKD-349 F2 Tab. and D113 Tab. in people with Chronic Renal Failure, run by Chong Kun Dang Pharmaceutical 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 28 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 Jan 2024. 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 CKD-349, D113 (time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours). 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 Jan 2024.