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Completed

NCT Number: NCT03174613

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

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

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LC51-0255

Drug

0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg

Placebo

Drug

0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg

Primary outcomes

  1. MTD determination

    Time frame: 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 outcomes

  1. Pharmacokinetic: Peak Plasma Concentration (Cmax)

    Time frame: Cmax:168 hours post dose

    Cmax

  2. Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)

    Time frame: AUCinf:168 hours post dose

    AUC

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2017
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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