A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment

Part of paid clinical trials in Miami, Florida.

Sponsor
Qpex Biopharma, Inc.
Study ID
NCT07104162
Phase
PHASE1
Status
Recruiting
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Conditions

  • Bacterial Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Cefiderocol/Xeruborbactam — DRUG
    A fixed dose combination of intravenous cefiderocol and intravenous xeruborbactam

Study Details

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

Key Dates

Start date
Sep 16, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2026
Completion
Dec 23, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label, Single Dose of IV Cefiderocol/Xeruborbactam
    Approximately 40 participants will be enrolled in total. Eight participants will be enrolled in each group (G) based on renal impairment (RI) determined by estimated glomerular function rate (eGFR) or need for intermittent hemodialysis (IHD) at screening: * G1: Mild RI (eGFR 60 \< 90 mL/min calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration equation \[CKP-EPI\]) adjusted for the participant's body surface \[BSA\]) * G2: Moderate RI (eGFR 30 to \< 60 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA) * G3: Severe RI (eGFR \< 30 mL/min calculated using the 2021 CKD-EPI equation) not receiving IHD therapy * G4: Healthy participants with normal renal function matched to participants in Groups 1 and 2 (Group 3 may be included) based on age, gender and body mass index (BMI) * G5: Participants with end stage renal disease (ESRD) receiving IHD All participants will receive a single dose of cefiderocol/xeruborbactam on Day 1.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) by participant and by group [ Time Frame: 11-22 days (+/- 2) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Miami Clinical PharmacologyMiamiFlorida33136
Richard Preston, MD
Richard Preston, MD (PRINCIPAL_INVESTIGATOR)
Orlando Clinical Research CenterOrlandoFlorida32809
Thomas Marbury, MD
Thomas Marbury, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami Clinical Pharmacology· Miami, FLOrlando Clinical Research Center· Orlando, FL

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