A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cefiderocol Plus Midazolam A total of 2 doses of midazolam and 45 doses of cefiderocol will be administered to each participant per specified dosing schedule. |
Drug: Midazolam
Syrup for oral administration
Drug: Cefiderocol
Liquid for IV infusion
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Time to Maximum Plasma Concentration (Tmax) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Area Under the Plasma Concentration-Time Curve (AUC) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Terminal Elimination Half-Life (t1/2,z) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Terminal Elimination Rate Constant (λz) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Mean Residence Time (MRT) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Apparent Total Clearance (CL/F) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
- Apparent Volume of Distribution (Vz/F) of Midazolam [0 (predose) up to 24 hours postdose on Day -1 to Day 16]
Secondary Outcome Measures
- Cmax of Cefiderocol [0 (predose) up to 24 hours postdose on Day 3 to Day 16]
- Tmax of Cefiderocol [0 (predose) up to 24 hours postdose on Day 3 to Day 16]
- AUC of Cefiderocol [0 (predose) up to 24 hours postdose on Day 3 to Day 16]
- CL of Cefiderocol [0 (predose) up to 24 hours postdose on Day 3 to Day 16]
- Number of Participants with Treatment-Emergent Adverse Events [Up to Day 23]
Eligibility Criteria
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 (ECG) at the Screening Visit and upon admission to the clinical research unit (CRU).
-
Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range of ≥ 18.5 to ≤ 32.0 kg/m2 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 mm Hg, diastolic blood pressure outside the range of 50 to 95 mm Hg, 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.
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Breast cancer within the past 10 years.
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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 mL 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.
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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 mg 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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Worldwide Clinical Trials | San Antonio | Texas | United States | 78217 |
Sponsors and Collaborators
- Shionogi
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2136R2118