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

Description

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

Conditions

Bacterial Infections

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Study Overview

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Study Details

Study overview

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

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

Condition
Bacterial Infections
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Minneapolis Clinic, Minneapolis, Minnesota, United States, 55114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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)

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Qpex Biopharma, Inc.,

Study Record Dates

2025-12