Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects

Conditions
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VA Drug Interactions

Intervention / Treatment
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* Drug: Midazolam
* Drug: Delafloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No clinically important abnormal physical findings. No clinically significant laboratory abnormalities. Normal (or abnormal but not clinically significant) ECG measurements. Body mass index between 18.0 and 32.0 kg/m2. Normal (or abnormal but not clinically significant) blood pressure and pulse rate measurements. methylxanthine-containing beverages or food Non-smoker Exclusion Criteria: Received any investigational drug within 8 weeks before administration of the first dose of the study drug Female who is pregnant, has a positive pregnancy test, or is breastfeeding. Positive test result for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, opiates, cannabinoids, methylenedioxymethamphetamine, cotinine, or alcohol in urine at Screening or Day -1. Positive screening test for hepatitis B surface antigen, hepatitis C, and/or human immunodeficiency virus antibodies. Any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug. Used any medication (prescription or over-the-counter, including health supplements and herbal remedies, with the exception of acetaminophen, as defined in exclusion number 8) within 2 weeks (4 weeks for drugs or substances known to inhibit or induce CYP enzymes and/or P-gp including St. John's wort [Hypericum perforatum]) or 5 half-lives (whichever is longer) before the first dose of study drug. Used an oral or IV antibiotic within 4 weeks of administration of the first dose of the study drug. Routinely or chronically used more than 2 g of acetaminophen daily. Performed strenuous activity, sunbathing, and/or contact sports within 96 hours (4 days) before entry into the clinical study site on Day -1, and for the duration of the study. Donated or lost greater than 400 mL of blood in the 30 days before administration of the first dose of the study drug. History of clinically significant GI disease, or gastroenteritis (vomiting or diarrhea) or any history of GI bleeding (excluding bleeding from hemorrhoids) History of any significant drug allergy History of any drug or alcohol abuse in the past 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam/Delafloxacin<br>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. | Drug: Midazolam<br>* Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.<br>Drug: Delafloxacin<br>* Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |