NCT03174613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

May 25, 2017

Last Update Submit

September 16, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Pharmacokinetic: Peak Plasma Concentration (Cmax)

    Cmax:168 hours post dose

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

    AUCinf:168 hours post dose

Study Arms (2)

LC51-0255

EXPERIMENTAL

tablets, PO

Drug: LC51-0255

Placebo

PLACEBO COMPARATOR

tablets, PO

Drug: Placebo

Interventions

LC51-0255DRUG

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

LC51-0255
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy male subjects
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

  • Kyung-Sang Yu, MD,M.B.A.

    Seoul National University Hospital, Clinical Trial Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 2, 2017

Study Start

May 31, 2017

Primary Completion

June 12, 2019

Study Completion

July 11, 2019

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)