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The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.
This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam/Delafloxacin | Experimental | Each subject will receive a single 5 mg oral dose of midazolam syrup on Day 1, oral 450 mg delafloxacin tablets twice daily (Q12h) for Days 3 to 8, and co-administered a single 5 mg oral dose of midazolam syrup in the AM on Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t | Days 1 and 8 | |
| Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-inf | Days 1 and 8 | |
| Midazolam and 1-hydroxymidazolam Plasma PK: Cmax | Days 1 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Cammarata, MD | Melinta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28495029 | Derived | Paulson SK, Wood-Horrall RN, Hoover R, Quintas M, Lawrence LE, Cammarata SK. The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-state Dosing of Delafloxacin. Clin Ther. 2017 Jun;39(6):1182-1190. doi: 10.1016/j.clinthera.2017.04.009. Epub 2017 May 9. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C477891 | delafloxacin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Delafloxacin | Drug | Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8 |
|
| D006571 | Heterocyclic Compounds |