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This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WCK 4873 | Experimental | 200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study |
|
| Placebo | Placebo Comparator | Visually matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WCK 4873 | Drug |
| ||
| Placebo Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing incidence of treatment emergent AEs | By abnormal clinical laboratory (including liver function tests) findings | Day 24 |
| Assessing incidence of treatment emergent AEs | By variation in physical examination | Day 24 |
| Assessing incidence of treatment emergent AEs | By abnormal findings in eye movement test and visual acuity test | Day 24 |
| Assessing incidence of treatment emergent AEs | By abnormal vital signs | Day 24 |
| Assessing incidence of treatment emergent AEs | variations in 12-lead electrocardiogram | Day 24 |
| Measure the pharmacokinetic parameter: Area Under Curve (AUC) | plasma PK parameters area under curve (AUC) | Day 10 |
| Measure the pharmacokinetic parameter-plasma PK concentration | Plasma concentration -Cmax | Day 10 |
| Measure the pharmacokinetic parameter- Time | Plasma PK parameter- Tmax | Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000627038 | nafithromycin |
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|
| Measure the pharmacokinetic parameter- Time |
Plasma PK parameter- T1/2 |
| Day 10 |