A Study To Evaluate The Safety, Pharmacokinetics/Pharmaco... | NCT03174613

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

NCT03174613

Sponsor

LG Chem

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

100Actual

Phase

Phase 1

Conditions

Healthy

Interventions

LC51-0255
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2017Actual

Primary Completion Date

Jun 12, 2019Actual

Completion Date

Jul 11, 2019Actual

First Submitted Date

May 25, 2017

First Submission Date that Met QC Criteria

May 31, 2017

First Posted Date

Jun 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2020

Last Update Posted Date

Sep 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LC51-0255	Experimental	tablets, PO	Drug: LC51-0255
Placebo	Placebo Comparator	tablets, PO	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LC51-0255	Drug	0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg	LC51-0255
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic: Peak Plasma Concentration (Cmax)	Cmax	Cmax:168 hours post dose
Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)	AUC

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Healthy male subjects

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-Sang Yu, MD,M.B.A.	Seoul National University Hospital, Clinical Trial Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided