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

NCT03858725 | Completed Phase 1

• 1 other identifier: 190BE18031
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-374 and D569

  Area under the CKD-374/ D569 concentration in blood-time curve from zero to final

  [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

  [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]

Study Arms (2)

D569/CKD-374 5mg

EXPERIMENTAL

1. Period 1: D569 Tab. 1T 2. Period 2: CKD-374 5mg Tab. 1T

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

Drug: D569 Tab.; Drug: CKD-374 5mg Tab.

Interventions

D569 Tab. DRUG

D569 Tab. 1T single oral administration under fasting condition

CKD-374 5mg/D569; D569/CKD-374 5mg

CKD-374 5mg Tab. DRUG

CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition

CKD-374 5mg/D569; D569/CKD-374 5mg

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kyung-Ho Jang

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: February 26, 2019
• Primary Completion: April 5, 2019
• Study Completion: May 8, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)