Rheumatoid ArthritisPhase 1NCT03858725
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers
A Phase 1 study testing D569 Tab. and CKD-374 5mg Tab. in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- D569 Tab. and CKD-374 5mg Tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2019to 8 May 2019
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject older than 19 years and less than 55 years at the screening
- Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a 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 within the last 3 years
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG, chest X-ray etc.)
- Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
- Individuals with the ability and willingness to participate during the study period
Who cannot join
- Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
- Individuals with the following laboratory test results: ALT or AST > 2x the upper limit of the normal range
- A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (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 smoked more than 20 cigarettes per day within 6 months prior to screening
- Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 3 months prior to the first dose of this study
Show all 24Show fewer
- Individuals with the following vital signs results at screening
- Individuals who had sitting blood pressure ≥90 mmHg or <140 mmHg (systolic) or ≥90 mmHg or <60 mmHg (diastolic)
- Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
- Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
- Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
- Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
- Individuals with severe acute/chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
- Individuals with hypersensitivity to ingredients used in the investigational product(s)
- Patients with serious infection (e.g., Sepsis) or active infection including localized infection or history of interstitial pneumonia
- Patients with active tuberculosis or history of tuberculosis
- Patients with hepatopathy
- Patients with an absolute neutrophil count (ANC) less than 1000 /ul
- Patients with an absolute lymphocyte count (ALC) less than 500 /ul
- Patients who have hemoglobin levels less than 9 g/dL
- Women who are pregnant or may be pregnant
- Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
- 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, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer
This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.
Read the detailed description
To healthy subjects of thirty-six (36), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed
- Conditions
- Rheumatoid Arthritis
- Being tested
- D569 Tab., CKD-374 5mg Tab.
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D569 Tab.Drug
D569 Tab. 1T single oral administration under fasting condition
CKD-374 5mg Tab.Drug
CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| D569/CKD-374 5mg | Experimental | 1. Period 1: D569 Tab. 1T
2. Period 2: CKD-374 5mg Tab. 1T Receives: Drug: D569 Tab.; Drug: CKD-374 5mg Tab. |
| CKD-374 5mg/D569 | Experimental | 1. Period 1: CKD-374 5mg Tab. 1T
2. Period 2: D569 Tab. 1T Receives: Drug: D569 Tab.; Drug: CKD-374 5mg Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-374 and D569
Area under the CKD-374/ D569 concentration in blood-time curve from zero to final
Measured: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours]
Cmax of CKD-374 and D569
The maximum CKD-374/ D569 concentration in blood sampling time t
Measured: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start26 Feb 2019
- Primary completion5 Apr 2019
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Ho Jang, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858725
- Sponsor's protocol ID
- 190BE18031
- Status last verified
- Jan 2020
- First submitted
- 27 Feb 2019
- Last updated
- 30 Jan 2020
- 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 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT03858725
- Acronym / sponsor ID
- 190BE18031
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 1 Mar 2019 (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, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.
Detailed description
To healthy subjects of thirty-six (36), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are collected up to 12hrs. 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 |
|---|---|---|
| D569/CKD-374 5mg | Experimental | Drug: D569 Tab., Drug: CKD-374 5mg Tab.1. Period 1: D569 Tab. 1T 2. Period 2: CKD-374 5mg Tab. 1T |
| CKD-374 5mg/D569 | Experimental | Drug: D569 Tab., Drug: CKD-374 5mg Tab.1. Period 1: CKD-374 5mg Tab. 1T 2. Period 2: D569 Tab. 1T |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy subject older than 19 years and less than 55 years at the screening
- Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG, chest X-ray etc.)
- Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
Key exclusion criteria (24 listed)
- Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
- Individuals with the following laboratory test results: ALT or AST > 2x the upper limit of the normal range
- A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (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 smoked more than 20 cigarettes per day within 6 months prior to 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 |
|---|---|---|
| D569 Tab.D569 Tab. 1T single oral administration under fasting condition | Drug | CKD-374 5mg/D569, D569/CKD-374 5mg |
| CKD-374 5mg Tab.CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition | Drug | CKD-374 5mg/D569, D569/CKD-374 5mg |
Primary outcome
AUCt of CKD-374 and D569
Time frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours]
Area under the CKD-374/ D569 concentration in blood-time curve from zero to final
Cmax of CKD-374 and D569
Time frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours]
The maximum CKD-374/ D569 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 30 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Kyung-Ho Jang principal investigator
Chonbuk 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 D569 Tab. and CKD-374 5mg Tab. in people with Rheumatoid Arthritis, 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 7 inclusion and 24 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 30 Jan 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?
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-374 and D569 (time frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 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 30 Jan 2020.