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The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment.
pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delafloxacin | Experimental | Single Dose 300 mg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delafloxacin | Drug | Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters: • AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz | Baseline through 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: AEs, clinical laboratory results (serum chemistry, coagulation, hematology, and urinalysis), vital sign measurements, 12-lead ECG measurements, and physical examination findings | Baseline through 72 hours post-dose |
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Inclusion Criteria:
Hepatically Impaired Subjects Only (Groups A, B, and C):
-Has a clinical diagnosis of cirrhosis and has been classified as having mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by the Child-Pugh classification system (Section 7.2).
Healthy Subjects Only (Group D):
-Must be in good health as determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram [ECG] results, and physical examination findings
Exclusion Criteria:
Hepatically Impaired Subjects Only (Groups A, B, and C):
Healthy Subjects Only (Group D):
-Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.
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| Name | Affiliation | Role |
|---|---|---|
| Sue K Cammarata, MD | CMO, MelintaTtherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melinta 112 Study Site | Miami | Florida | 33136 | United States | ||
| Melinta 112 Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27570245 | Derived | Hoover R, Marbury TC, Preston RA, Quintas M, Lawrence LE, Paulson SK, Luke DR, Cammarata SK. Clinical Pharmacology of Delafloxacin in Patients With Hepatic Impairment. J Clin Pharmacol. 2017 Mar;57(3):328-335. doi: 10.1002/jcph.817. Epub 2016 Oct 14. |
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| ID | Term |
|---|---|
| C477891 | delafloxacin |
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| Orlando |
| Florida |
| 32809 |
| United States |