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The purpose of this study is to evaluate the steady-state intrapulmonary disposition of delafloxacin in healthy adult participants.
This study will evaluate the safety and pharmacokinetics (PK) of delafloxacin in healthy adult participants by assessing the intrapulmonary disposition in adults receiving 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delafloxacin | Experimental | Dosing will be initiated on Day 1. All participants will receive 300-mg delafloxacin as a 1-hour intravenous infusion every 12 hours (± 15 minutes) for a total of 7 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delafloxacin | Drug | In this study, thirty subjects who meet the entry criteria will be assigned to 1 of 5 groups (A, B,C, D, or E) to receive 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Delafloxacin plasma PK:Tmax | Day 4 | |
| Delafloxacin plasma PK: Cmax | Day 4 | |
| Delafloxacin plasma PK: AUCÏ„ | Day 4 | |
| Delafloxacin plasma PK: AUC0-t | Day 4 | |
| Delafloxacin plasma PK: AUCinf | Day 4 | |
| Delafloxacin plasma PK: T1/2 | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue K Cammarata, MD | CMO, MelintaTherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31988972 | Derived | Horcajada JP, Salata RA, Alvarez-Sala R, Nitu FM, Lawrence L, Quintas M, Cheng CY, Cammarata S; DEFINE-CABP Study Group. A Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP). Open Forum Infect Dis. 2019 Dec 5;7(1):ofz514. doi: 10.1093/ofid/ofz514. eCollection 2020 Jan. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C477891 | delafloxacin |
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