Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03858725
• Date of registration: 27/02/2019
• Prospective Registration: No
• Primary sponsor: Chong Kun Dang Pharmaceutical
• Public title: Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers
• Scientific 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
• Date of first enrolment: February 26, 2019
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03858725
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Kyung-Ho Jang
• Affiliation: Chonbuk National University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy subject older than 19 years and less than 55 years at the screening

2. 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

3. Individuals without congenital/chronic diseases and without abnormal symptoms or
diagnosis based on a medical examination within the last 3 years

4. 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.)

5. 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

6. Individuals with the ability and willingness to participate during the study period

Exclusion Criteria:

1. 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.)

2. 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

3. Individuals with the following laboratory test results: ALT or AST > 2x the upper
limit of the normal range

4. 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)

5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to
screening

6. 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

7. 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)

8. Individuals with a medical history of significant alcohol abuse or drug abuse within
one year prior to the screening

9. 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)

10. Individuals who had taken prescription or nonprescription drugs within the 10 days
prior to the first dose of investigational product(s)

11. 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)

12. 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

13. Individuals with hypersensitivity to ingredients used in the investigational
product(s)

14. Patients with serious infection (e.g., Sepsis) or active infection including localized
infection or history of interstitial pneumonia

15. Patients with active tuberculosis or history of tuberculosis

16. Patients with hepatopathy

17. Patients with an absolute neutrophil count (ANC) less than 1000 /ul

18. Patients with an absolute lymphocyte count (ALC) less than 500 /ul

19. Patients who have hemoglobin levels less than 9 g/dL

20. Women who are pregnant or may be pregnant

21. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption etc.

22. Patients with nephropathy (eGFR<60 ml/min/1.73 m2)

23. Individuals who were deemed to be inappropriate to participate in the study by the
investigator



Age minimum: 19 Years
Age maximum: 54 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: D569 Tab.

Drug: CKD-374 5mg Tab.

Primary Outcome(s)

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]]

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]]

Secondary ID(s)

190BE18031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors