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Cephalosporin Antibiotic
Cefiderocol Plus Midazolam for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Shionogi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (predose) up to 24 hours postdose on day -1 (midazolam alone at baseline) and day 15
Awards & highlights
Study 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
You may be eligible if you check “Yes” for the criteria belowSelect...
You are at least 50 kilograms (kg) and have a body mass index (BMI) within the range of ≥ 18.5 to ≤ 32.0 kg/m2 at the Screening Visit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (predose) up to 24 hours postdose on day -1 (midazolam alone at baseline) and day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (predose) up to 24 hours postdose on day -1 (midazolam alone at baseline) and day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Total Clearance (CL/F) of Midazolam
Apparent Volume of Distribution (Vz/F) of Midazolam
Area Under the Concentration-time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) of Midazolam
+6 moreSecondary outcome measures
Area Under the Plasma Concentration-time Curve Over the Dosing Interval τ (8 Hours) (AUC0-τ) of Cefiderocol
CL of Cefiderocol
Cmax of Cefiderocol
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cefiderocol Plus MidazolamExperimental Treatment2 Interventions
A total of 2 doses of midazolam and 45 doses of cefiderocol was administered to each participant per specified dosing schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
FDA approved
Cefiderocol
FDA approved
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ShionogiLead Sponsor
115 Previous Clinical Trials
41,247 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Worldwide Clinical Trials
What portion of applicants met pre-screening criteria?
Did not meet criteria
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