CompletedPhase 1

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

United States60 participantsStarted 2024-09-04

Plain-language summary

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, 18 to 55 years of age (inclusive) at the time of signing the informed consent. * Body mass index (BMI) ≥ 18.5 and 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) * Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile * Voluntary consent to participate in the study. Exclusion Criteria: * History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. * A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration * Females who are pregnant or lactating * Documented hypersensitivity reaction or anaphylaxis to any medication. History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence and nature of treatment emergent adverse events (TEAE)

Timeframe: up to day 17 or up to day 21

Number of patients with changes from baseline in safety parameters

Timeframe: up to day 17 or up to day 21

Maximum plasma concentration (Cmax)

Timeframe: up to day 17 or up to day 21

Time to maximum plasma concentration (Tmax)

Timeframe: up to day 17 or up to day 21

Area under the plasma concentration versus time curve (AUC)

Timeframe: up to day 17 or up to day 21

Terminal elimination half-life (t1/2,z)

Timeframe: up to day 17 or up to day 21

Terminal elimination rate constant (λz)

Timeframe: up to day 17 or up to day 21

Trial details

NCT IDNCT06547554

SponsorQpex Biopharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-27

View on ClinicalTrials.gov More Bacterial Infections trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The incidence and nature of treatment emergent adverse events (TEAE)

Timeframe: up to day 17 or up to day 21

Number of patients with changes from baseline in safety parameters

Timeframe: up to day 17 or up to day 21

Maximum plasma concentration (Cmax)

Timeframe: up to day 17 or up to day 21

Time to maximum plasma concentration (Tmax)

Timeframe: up to day 17 or up to day 21

Area under the plasma concentration versus time curve (AUC)

Timeframe: up to day 17 or up to day 21

Terminal elimination half-life (t1/2,z)

Timeframe: up to day 17 or up to day 21

Terminal elimination rate constant (λz)

Timeframe: up to day 17 or up to day 21