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NCT04187456 · ClinicalTrials.gov registry record · Phase 1

A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT04187456 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 14 participants.

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The verdict

NCT04187456, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

This study will be an open label, 2 period, fixed sequence study in healthy male subjects, performed at a single study center in the Unites States of America. The purpose of this study is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450 (CYP) 3A substrate.

Interventions

  • DRUG Midazolam
  • DRUG Savolitinib

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2019-12-27
Est. Completion 2020-03-06
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04187456

The ClinicalTrials.gov registry entry for NCT04187456 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. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.

NCT04187456 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04187456 about?

NCT04187456 is a clinical study titled "A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body". This study will be an open label, 2 period, fixed sequence study in healthy male subjects, performed at a single study center in the Unites States of America. The purpose of this study is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450 (CYP) 3A substrate.

What is the current status of trial NCT04187456?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-12-27. Estimated completion is 2020-03-06.

What interventions are being tested in trial NCT04187456?

The interventions under investigation include: Midazolam (DRUG), Savolitinib (DRUG).

Who is sponsoring clinical trial NCT04187456?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

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.