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.
- 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
- 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
- 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