A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment
Able to understand the study conduct and tasks required of the participants, sign the informed consent form and willing to cooperate with all tests and examinations required by the protocol.
Aged 18 to 80 years, inclusive, at the time of consent.
If male, agrees to be sexually abstinent or agrees to use 2 approved methods of contraception (refer to Inclusion Criterion 4) when engaging in heterosexual activity from Day -1 through 90 days following the last administration of the study intervention, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
If female of childbearing potential, must either be sexually abstinent for 14 days prior to Day -1 and remain so through 30 days following dosing of the study intervention or have been using (or agree to use) 2 acceptable methods of birth control when engaging in heterosexual activity
Has unstable or new medical condition(s)
Has had surgery under general anesthesia within the past 3 months prior to Day -1, determined by the investigator to be clinically relevant.
Documented hypersensitivity reaction or anaphylaxis to any medication.
History of seizures, convulsions
Sequential
Cefiderocol/Xeruborbactam
DrugA fixed dose combination of intravenous cefiderocol and intravenous xeruborbactam
Incidence of treatment-emergent adverse events (TEAEs) by participant and by group
Number of participants with treatment-emergent adverse events by severity and relationship to treatment
Number of participants with changes from baseline in safety parameters
Number of participants with changes in safety parameters before and after dosing by subject and group
Maximum plasma concentration measurements by subject and by group (Cmax)
Comparison will be performed between the groups for maximum plasma concentration (Cmax).
Time to maximum plasma concentration (Tmax)
Comparison will be performed between the groups for time to maximum plasma concentration (Tmax)
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Qpex Biopharma, Inc.
Lead sponsor
Shionogi Inc.
Collaborator
Biomedical Advanced Research and Development Authority
Collaborator
