Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360343
• Other study ID #: LG-SGCL003
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Drug:
• Film-coated tablet
uncoated tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University College of Medicine and Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Outcome Measures	Peak Plasma Concentration (Cmax)	baseline,during the procedure
Primary	Pharmacokinetic Outcome Measures	Area under the plasma concentration versus time curve (AUC)	baseline,during the procedure