Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

Sponsor

LegoChem Biosciences, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT04939779

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

42.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch# 1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of "LCB01-0371(Batch#1650006)" and "LCB01-0371(Batch#3183817R)" in Healthy Adult Subjects

Actual Study Start Date :

Jan 14, 2021

Actual Primary Completion Date :

Jan 24, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)	Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Oral administration Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Oral administration
Experimental: Group B Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)	Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Oral administration Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Oral administration

Arm

Intervention/Treatment

Experimental: Group A

Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)

Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)

Oral administration

Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Oral administration

Experimental: Group B

Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)

Oral administration

Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Oral administration

Outcome Measures

Primary Outcome Measures

Pharmacokinetic evaluation: The observed maximum concentration(Cmax) [0-12hours]
Pharmacokinetic parameters will be assessed using non-compartmental method
Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast) [0-12hours]
Area under the plasma concentration curve from zero until the last measurable concentration

Secondary Outcome Measures

Pharmacokinetic evaluation: Time to reach Cmax(Tmax) [0-12hours]
Pharmacokinetic parameters will be assessed using non-compartmental method
Pharmacokinetic evaluation: Elimination half-life(t1/2) [0-12hours]
Pharmacokinetic parameters will be assessed using non-compartmental method
Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F) [0-12hours]
Pharmacokinetic parameters will be assessed using non-compartmental method
Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F) [0-12hours]
Pharmacokinetic parameters will be assessed using non-compartmental method
Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf) [0-12hours]
Area under the curve from time 0 extrapolated to infinite time

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

A person who is a healthy adult aged between 19 and 45 years old with the result of BMI between 18.0 kg/m2 and 28.0 kg/m2
A healthy adult whose weight is over 50 kg
A person who is deemed suitable for a clinical trial subject in physical examination, vital sign tests, diagnostic examination, and 12-lead ECG by the medical doctor, etc.

Exclusion Criteria:

A person who has a clinically significant history of the disease, such as liver, kidney, gastrointestinal disease, respiratory tract disease, muscular-skeletal disease, endocrine disease, nervous system disease, blood ∙ tumor disease, cardiovascular disease, etc.
A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620

Sponsors and Collaborators

LegoChem Biosciences, Inc

Investigators

Principal Investigator: Jae-Yong Chung, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LegoChem Biosciences, Inc

ClinicalTrials.gov Identifier:

NCT04939779

Other Study ID Numbers:

LCB01-0371-18-1-08

First Posted:

Jun 25, 2021

Last Update Posted:

Jun 25, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delpazolid

Oxazolidinones

Study Results

No Results Posted as of Jun 25, 2021