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

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

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.

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