Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Double blind, randomized, placebo control, multiple dose, dose escalation study
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCB01-0371 800mg | Experimental | LCB01-0371 800mg |
|
| LCB01-0371 800mg BID | Experimental | LCB01-0371 800mg BID |
|
| LCB01-0371 1200mg BID | Experimental | LCB01-0371 1200mg BID |
|
| Placebo | Placebo Comparator | LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB01-0371 800mg | Drug | LCB01-0371 800mg |
| |
| LCB01-0371 800mg BID |
| Measure | Description | Time Frame |
|---|---|---|
| No of Adverse events | From date of randomization until follow up after 3 days from last hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Cmax(Peak plasma concentration) | Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days | 0(predose), 0.5, 1, 2, 4, 8 and 12hours |
| Pharmacokinetics: AUC(Area under the curve) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Young Lag Cho, Ph.D. | Legochembioscience | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | Gyeonggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29069400 | Derived | Choi Y, Lee SW, Kim A, Jang K, Nam H, Cho YL, Yu KS, Jang IJ, Chung JY. Safety, tolerability and pharmacokinetics of 21 day multiple oral administration of a new oxazolidinone antibiotic, LCB01-0371, in healthy male subjects. J Antimicrob Chemother. 2018 Jan 1;73(1):183-190. doi: 10.1093/jac/dkx367. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000627008 | delpazolid |
| C494814 | BID protein, human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
LCB01-0371 800mg BID |
|
| LCB01-0371 1200mg BID | Drug | LCB01-0371 1200mg BID |
|
| Placebo | Drug | Placebo |
|
Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days
| 0(predose), 0.5, 1, 2, 4, 8 and 12hours |