Clinical trial NCT04360343: Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
Official title: A Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 Criteria:

1. Healthy males and females between the age of 19 and 45 at the screening visit
2. Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit
3. Subjects who were confirmed to be healthy based on the medical history
4. Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent

Exclusion Criteria:

1. 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
2. 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
3. Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit
4. 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
5. Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
6. 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
7. 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)
8. 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)
9. 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
10. Subjects who unable to take the food provided by the study institution
11. Subjects who with a positive result in the serology test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test)
12. Other cases that the investigator consider unsuitable as the subject

Primary outcomes:
measure: Pharmacokinetic Outcome Measures
timeFrame: baseline,during the procedure
measure: Pharmacokinetic Outcome Measures
timeFrame: baseline,during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine and Hospital
Study officials:
References: