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Austin, Texas 78744


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02505997


Primary Contact:

Study Director
Sue Cammarata, MD
Melinta Therapeutics, Inc.


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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