A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LC51-0255; Drug: Placebo

• Registration Number: NCT03174613
• Lead Sponsor: LG Chem

Brief Summary

1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects

2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects

3. To evaluate bioavailability of LC51-0255

Detailed Description

For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.

Study Timeline

• Study First Submitted: 2017-05-25
• Study Start: 2017-05-31
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-02
• Primary Completion: 2019-06-12
• Study Completion: 2019-07-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Healthy male subjects aged 19~45 years at screening.
• Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)

Exclusion Criteria

• History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease
• Exclusions Related to Laboratory Results: Platelet count < 100,000/μL, Hgb < 8.5 g/dL, Neutrophils < 1.5 /μL, Absolute WBC count < 3500/μL, Absolute lymphocyte count < 800/μL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LC51-0255	LC51-0255	tablets, PO
Placebo	Placebo	tablets, PO

Primary Outcome Measures

Name	Time	Method
MTD determination	Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study	Safety and Tolerability

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic: Peak Plasma Concentration (Cmax)	Cmax:168 hours post dose	Cmax
Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)	AUCinf:168 hours post dose	AUC

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of