A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
Condition: Healthy Volunteers
Intervention: Midazolam; Cefiderocol
Intervention description: Syrup for oral administration; Liquid for intravenous infusion
Intervention MeSH terms: Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effect of repeated doses of cefiderocol on the
      PK of midazolam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are overtly healthy as determined by medical evaluation, including
             medical history, physical examination, clinical laboratory tests, vital sign
             measurements, and 12-lead electrocardiography at the Screening Visit and upon
             admission to the clinical research unit (CRU).

          -  Body weight ≥ 50 kilograms (kg) and body mass index within the range of ≥ 18.5 to ≤
             32.0 kg/meter squared at the Screening Visit.

        Exclusion Criteria:

          -  History or presence of/significant history of or current cardiovascular, respiratory,
             hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological
             disorders capable of significantly altering the absorption, metabolism, or elimination
             of drugs; constituting a risk when taking the study intervention; or interfering with
             the interpretation of data.

          -  Systolic blood pressure outside the range of 90 to 145 millimeters of mercury (mmHg),
             diastolic blood pressure outside the range of 50 to 95 mmHg, pulse rate outside the
             range of 40 to 100 beats per minute, or blood pressure or pulse values considered
             clinically significant by the investigator at the Screening Visit or upon admission to
             the CRU. Abnormal values may be retested once.

          -  Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell
             or squamous epithelial carcinomas of the skin that have been resected with no evidence
             of metastatic disease for 3 years.

          -  Breast cancer within the past 10 years.

          -  Past use of over-the-counter or prescription medication, including herbal medications,
             traditional Chinese medicines, vitamins, minerals, dietary supplements, and vaccines
             within 14 days (or 5 terminal half-lives, whichever is longer) prior to admission to
             the CRU (which will occur on Day -2) or intended use of any of the above throughout
             the study enrollment.

          -  Significant blood loss of ≥ 500 milliliters or blood or plasma donation within 56 days
             prior to the Screening Visit until completion of the study, or from the Screening
             Period until admission to the CRU through completion of the study.

          -  History of coronavirus disease 2019 (COVID-19) infection within 14 days prior to the
             Screening Visit or admission, or close contact with a COVID-19 patient in the days
             prior to the Screening Visit or admission as reported by the participant and the
             participant's medical history.

          -  History of drug or alcohol abuse/addiction.

          -  Regularly consumes excessive amounts of caffeine, defined as > 6 servings of coffee,
             tea, caffeinated soft drinks, or other caffeinated beverages per day (1 serving is
             approximately equivalent to 120 milligrams of caffeine).

          -  Used tobacco- or nicotine-containing products (including cigarette, pipe, cigar,
             chewing tobacco, nicotine patch, or nicotine gum) within 6 months prior to admission
             to the CRU or refuses to refrain from using tobacco- or nicotine-containing products
             throughout the study (including Follow-up Period).