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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Midazolam
  • DRUG Cefiderocol

Study Locations (1)

Texas

  • Worldwide Clinical Trials - San Antonio

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2022-05-24
Est. Completion 2022-07-13
Phase Phase 1

Sponsor

Shionogi

54 total trials

What the Registry Record Tells You About NCT05395104

The ClinicalTrials.gov registry entry for NCT05395104 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.