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

NCT04360343 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-SGCL003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic Outcome Measures

  Peak Plasma Concentration (Cmax)

  baseline,during the procedure

• Pharmacokinetic Outcome Measures

  Area under the plasma concentration versus time curve (AUC)

  baseline,during the procedure

Study Arms (2)

LC51-0255 film-coated tablet

EXPERIMENTAL

Drug: LC51-0255

Drug: Film-coated tablet

LC51-0255 uncoated tablet

ACTIVE COMPARATOR

Drug: LC51-0255

Drug: Film-coated tablet

Interventions

Film-coated tablet DRUG

uncoated tablet

LC51-0255 film-coated tablet; LC51-0255 uncoated tablet

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Seoul National University College of Medicine and Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

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

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 24, 2020
• Study Start: July 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

KR (1)