VA Drug Interactions
Conditions
Brief summary
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
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.
Interventions
DRUGMidazolam
Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.
DRUGDelafloxacin
Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8
Sponsors
Melinta Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed