Worldwide Clinical Trials
San Antonio, Texas, 78217, United States
NCT Number: NCT05395104
The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
San Antonio, Texas, 78217, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Syrup for oral administration
Liquid for intravenous infusion
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Cmax is reported as nanograms/milliliter (ng/mL). Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Tmax is reported in hours (hrs). Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. AUC0-last was calculated using the linear up/log down trapezoidal method and is reported as nanograms times hours/milliliter (ng*hrs/mL). Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. AUC0-inf was calculated as: AUC0-last + [Clast/λz], where Clast is the last measured concentration and λz is the plasma terminal elimination rate constant on Days -1 and 15. Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. t1/2,z was calculated as: (ln2)/λz on Days -1 and 15. Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. λz is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase on Days -1 and 15 and is reported as 1/hours (1/h). Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. MRT was calculated as: AUMC0-inf/AUC0-inf, and AUMC0-inf is the area under the first moment curve extrapolated to infinity on Days -1 and 15. Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. CL/F was calculated as: Dose/AUC0-inf on Days -1 and 15 and is reported as liters/hr. Day -1 is defined as Baseline.
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Vz/F was calculated as: Dose/AUC0-inf/λz on Days -1 and 15 and is reported as liters. Day -1 is defined as Baseline.
Time frame: Day 15
This outcome measure presents the pharmacokinetics of cefiderocol when coadministered with midazolam. Cmax is reported as micrograms/milliliter (μg/mL).
Time frame: Day 15
This outcome measure presents the pharmacokinetics of cefiderocol when coadministered with midazolam.
Time frame: Day 15
This outcome measure presents the pharmacokinetics of cefiderocol when coadministered with midazolam. AUC0-τ was calculated by the linear up/log down trapezoidal method and is reported as micrograms times hours/milliliter (μg*hrs/mL).
Time frame: Day 15
This outcome measure presents the PK of cefiderocol when coadministered with midazolam. CL was calculated as: Dose/AUC0-τ on Day 15.
Shionogi
Industry
A Phase 1, Open-label, 1-sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Cefiderocol on the Pharmacokinetics of Midazolam in Healthy Adult Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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