Acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacteria pneumonia (CABP) Other
Conditions
Interventions
This is a partially-randomised open-label study. This healthy volunteer study will measure blood levels of a new liquid formulation of the test medicine, and investigate whether the liquid formulation
up to 3 doses of the liquid formulation and one dose of the existing tablet formulation, with a minimum washout of 4 days between doses. Up to two doses of the new liquid formulation may be given with
the order in which they receive these doses will be randomised. In Period 3 and optional Period 4, they will receive single doses up to 600 mg delafloxacin Powder for Oral Suspension, reconstituted wi
Sponsors
Melinta Subsidiary Corp. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent. 2. Must be willing and able to communicate and participate in the whole study. 3. Aged 18 to 55 years inclusive at the time of signing informed consent. 4. Must agree to adhere to contraception requirements defined in the Clinical Protocol and Participant Information Sheet and Informed Consent Form. 5. Healthy males or non-pregnant, non-lactating healthy females. 6. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening. 7. Weight =50 kg at screening.
Exclusion criteria
Exclusion criteria: 1. SAR (severe adverse reaction) or serious hypersensitivity to any drug or formulation excipients. 2. Any history of hypersensitivity to delafloxacin or any other fluroquinolones or previous history of tendon disorders related to fluroquinolone administration. 3. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active. 4. History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorders. 5. Subjects with a history of cholecystectomy or gallstones. 6. Acute diarrhoea or constipation in the 7 days before the predicted Day 1. If screening occurs >7 days before the Day 1, this criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day. 7. Subject has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold. 8. Subject does not agree to the consumption of, or has any known allergies to, the formulation excipients. 9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening or admission. 10. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator. Subjects with Gilbert’s Syndrome are not allowed. 11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) 1 and 2 antibody results. 12. Females who are pregnant or lactating (all female subjects must have a negative highly sensitive urine or serum pregnancy test). 13. Subjects who have received any IMP in a clinical research study within the 90 days of the planned first dose date, or less than 5 elimination half-lives prior to the planned first dose date, whichever is longer. 14. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood. 15. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day, hormonal contraception, or HRT) in the 14 days before the first dose of IMP. Exceptions may apply, as determined by the Investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study. 16. Subjects who are taking, or have taken, any antibacterial medications, antacids, medications containing multivalent cations or metal cations, multivitamin preparations containing zinc or iron, or didanosine buffered tablets within 14 days prior to the first dose of IMP. 17. Subjects who have had a COVID-19 vaccine within 2 days (48 hours) prior to admission. 18. History of any drug or alcohol abuse in the past 2 years. 19. Regular alcohol consumption in males >21 units per week and in females >14 units per week (1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Results of the formal statistical analysis of overall exposure (AUC) for delafloxacin Powder for Oral Suspension compared to oral delafloxacin Tablet reference measured using blood samples taken from Day 1 of Period 1 to Day 3 of the final study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic parameters measured using blood samples taken from Day 1 of Period 1 until Day 3 of the final study period. 2. Results of the formal statistical analysis of overall exposure (AUC) for delafloxacin Powder for Oral Suspension in the fed state compared to the fasted state measured using blood samples taken from Day 1 of Period 1 until Day 3 of the final study period. 3. Safety and tolerability measured using the incidence of adverse events and serious adverse events, and changes from baseline for vital signs, electrocardiograms, physical examinations and laboratory safety tests from Day -1 until discharge from the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactMike Snyder
Outcome results
None listed