Chronic Hepatitis bPhase 1NCT04676893
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
A Phase 1 study testing D418 Tab. and CKD-388 Tab. in people with Chronic Hepatitis b, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- D418 Tab. and CKD-388 Tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2021to 18 May 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- BMI = Weight(kg)/ Height(m)2
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) 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 tail
Who cannot join
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- Thiazolidinedione
- DPP-4 inhibitor
Show all 28Show fewer
- Metformin
- Any clinically significant chronic medical illness.
- Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Individuals with one of the following laboratory test results in screening
- AST, ALT > UNL (upper normal limit) x 3
- Creatinine clearance ≤ 80 mL/min
- In ECG result, QTc > 450 msec
- hCG(+) (only women)
- Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- Use of any prescription drugs within 14 days prior to study drug administration.
- Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
- History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
- Individuals who cannot eat standard meal provided from clinical trial center.
- Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
- Individuals who had received a blood transfusion within 30 days prior to study drug administration.
- Exposure to any investigational drug within 6 months prior to the first IP administration.
- Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
- Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stop drinking.
- Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
- Pregnant or women who may be pregnant
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul
Ji-Young Park, Professor
About this study
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
Read the detailed description
To healthy subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Chronic Hepatitis b
- Being tested
- D418 Tab., CKD-388 Tab.
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D418 Tab.Drug
Also called Reference
1T
CKD-388 Tab.Drug
Also called Test
1T
| Study group | Role | What they receive |
|---|---|---|
| Reference-Test | Experimental | Not described Receives: Drug: D418 Tab.; Drug: CKD-388 Tab. |
| Test-Reference | Experimental | Not described Receives: Drug: D418 Tab.; Drug: CKD-388 Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-388, D418
Area under the CKD-388/D418 concentration in blood-time curve from zero to final
Measured: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Cmax of CKD-388, D418
The maximum CKD-388/D418 concentration in blood sampling time t
Measured: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start26 Feb 2021 (estimated)
- Primary completion11 May 2021 (estimated)
- Study completion18 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676893
- Sponsor's protocol ID
- A99_02BE2002
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 21 Dec 2020
- 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 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04676893
- Acronym / sponsor ID
- A99_02BE2002
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (estimated)
- Primary completion
- 11 May 2021 (estimated)
- Study completion
- 18 May 2021 (estimated)
- First posted
- 21 Dec 2020 (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 an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
Detailed description
To healthy subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference-Test | Experimental | Drug: D418 Tab., Drug: CKD-388 Tab. |
| Test-Reference | Experimental | Drug: D418 Tab., Drug: CKD-388 Tab. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) 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 tail
Key exclusion criteria (28 listed)
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- Any clinically significant chronic medical illness.
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 |
|---|---|---|
| D418 Tab.Also: Reference1T | Drug | Reference-Test, Test-Reference |
| CKD-388 Tab.Also: Test1T | Drug | Reference-Test, Test-Reference |
Primary outcome
AUCt of CKD-388, D418
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Area under the CKD-388/D418 concentration in blood-time curve from zero to final
Cmax of CKD-388, D418
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
The maximum CKD-388/D418 concentration in blood sampling time t
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- 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.
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 D418 Tab. and CKD-388 Tab. in people with Chronic Hepatitis b, 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 5 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: status not confirmed, as of the sponsor's last update on 21 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Young Park, Professor (+82-2-920-6288, jypark21@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of CKD-388, D418 (time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 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 21 Dec 2020.