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NCT05395104 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
A Phase 1 study of Healthy Volunteers, sponsored by Shionogi.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05395104: Completed Phase 1 study of Healthy Volunteers, sponsored by Shionogi.
NCT05395104 is a Phase 1 study of Healthy Volunteers that has completed, run by Shionogi. The registered enrollment target is 14 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05395104, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Cefiderocol
Study Locations (1)
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2022-07-13 |
| Phase | Phase 1 |
What the finished NCT05395104 record still lists
NCT05395104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT05395104 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05395104 about?
NCT05395104 is a clinical study titled "A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants". The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.
What is the current status of trial NCT05395104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-05-24. Estimated completion is 2022-07-13.
What conditions does trial NCT05395104 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05395104?
The interventions under investigation include: Midazolam (DRUG), Cefiderocol (DRUG).
Who is sponsoring clinical trial NCT05395104?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05395104 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05395104's enrollment target sits among peer trials
14 245th of 283 higher than 35 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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