Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects
- Registration Number
- NCT02505997
- Lead Sponsor
- Melinta Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Midazolam/Delafloxacin Midazolam 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. Midazolam/Delafloxacin Delafloxacin 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States