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Primary
- To investigate the safety and tolerability of LCB01-0371 after a single oral dose
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCB01-0371 | Experimental | active |
|
| Linezolid | Experimental | comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB01-0371 | Drug | LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5) |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, M.D., Ph. D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29712654 | Derived | Cho YS, Lim HS, Lee SH, Cho YL, Nam HS, Bae KS. Pharmacokinetics, Pharmacodynamics, and Tolerability of Single-Dose Oral LCB01-0371, a Novel Oxazolidinone with Broad-Spectrum Activity, in Healthy Volunteers. Antimicrob Agents Chemother. 2018 Jun 26;62(7):e00451-18. doi: 10.1128/AAC.00451-18. Print 2018 Jul. |
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| ID | Term |
|---|---|
| C000627008 | delpazolid |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Linezolid | Drug | Linezolid 600 mg (Cohort 9) none |
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |