NCT05395104

A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Midazolam	Syrup for oral administration
DRUG	Cefiderocol	Liquid for intravenous infusion

Timeline

• Start date: 2022-05-24
• Primary completion: 2022-07-13
• Completion: 2022-07-13
• First posted: 2022-05-27
• Last updated: 2023-12-14
• Results posted: 2023-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study