Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LCB01-0371 800mg; Drug: LCB01-0371 1200mg BID; Drug: Placebo; Drug: LCB01-0371 800mg BID

• Registration Number: NCT02540460
• Lead Sponsor: LigaChem Biosciences, Inc.

Brief Summary

The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Detailed Description

Double blind, randomized, placebo control, multiple dose, dose escalation study

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-13
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-01
• Last Update Submitted: 2015-09-01
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Healthy male between 20 and 45 years of age at the time of screening
2. Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion
4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements.

Exclusion Criteria

1. History of liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
4. History of drug abuse or positive result at urine drug screening
5. AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCB01-0371 800mg	LCB01-0371 800mg	LCB01-0371 800mg
LCB01-0371 1200mg BID	LCB01-0371 1200mg BID	LCB01-0371 1200mg BID
Placebo	Placebo	LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID
LCB01-0371 800mg	Placebo	LCB01-0371 800mg
LCB01-0371 800mg BID	LCB01-0371 800mg BID	LCB01-0371 800mg BID
LCB01-0371 800mg BID	Placebo	LCB01-0371 800mg BID
LCB01-0371 1200mg BID	Placebo	LCB01-0371 1200mg BID

Primary Outcome Measures

Name	Time	Method
No of Adverse events	From date of randomization until follow up after 3 days from last hospital discharge

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Cmax(Peak plasma concentration)	0(predose), 0.5, 1, 2, 4, 8 and 12hours	Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days
Pharmacokinetics: AUC(Area under the curve)	0(predose), 0.5, 1, 2, 4, 8 and 12hours	Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days

Trial Locations

Locations (1)

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