Status:
COMPLETED
Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
Lead Sponsor:
LG Chem
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.
Eligibility Criteria
Inclusion
- Healthy males and females between the age of 19 and 45 at the screening visit
- Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit
- Subjects who were confirmed to be healthy based on the medical history
- Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent
Exclusion
- Subjects with a clinically significant disease or history in liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system or cardiovascular system
- Subjects with a disease (e.g., Crohn's disease, etc.) or history of surgery (except for simple appendectomy and herniotomy) in gastrointestinal system which may affect the absorption of the investigational product
- Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit
- Subjects who had donated whole blood within 2 months, component blood within 1 month, or received transfusion within 1 month prior to the first administration day
- Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
- Subjects who had eaten grapefruit/caffeine-containing food within 3 days prior to the first hospitalization or subjects who could not stop taking food containing grapefruit or caffeine from 3 days prior to hospitalization to the discharge day
- Subjects who had taken any prescription drug or herbal medicine within 2 weeks or any over the counter (OTC) drug within 1 week prior to the first administration day (however, subjects fulfilling other conditions could participate in the study at the investigator's discretion)
- Subjects who taking excessive caffeine or alcohol or heavy smoker (caffeine \> 5 units/day, alcohol \> 21 units/week (1 unit = 10 mL as pure alcohol), smoking \> 10 cigarettes/day)
- Subjects who had a history of tuberculosis (TB) infection or a positive result in the Quantiferon TB-Gold test and the chest X-ray in the screening tests
- Subjects who unable to take the food provided by the study institution
- Subjects who with a positive result in the serology test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test)
- Other cases that the investigator consider unsuitable as the subject
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04360343
Start Date
July 1 2020
End Date
December 1 2020
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University College of Medicine and Hospital
Seoul, South Korea