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NCT04497883 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants

A Phase 1 study, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT04497883 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 24 participants.

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The verdict

NCT04497883, a Phase 1 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability of maribavir administered as a single oral dose in healthy, adult participants of Japanese descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this study will assess the dose-proportionality of PK of maribavir in healthy, adult participants of Japanese descent.

Interventions

  • DRUG Maribavir (400 mg)
  • DRUG Maribavir (200 mg)
  • DRUG Maribavir (800 mg)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-08-07
Est. Completion 2020-11-12
Phase Phase 1

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT04497883

The ClinicalTrials.gov registry entry for NCT04497883 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Maribavir (400 mg) is the first listed.

NCT04497883 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04497883 about?

NCT04497883 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants". The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability of maribavir administered as a single oral dose in healthy, adult participants of Japanese descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this study will assess the do...

What is the current status of trial NCT04497883?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-08-07. Estimated completion is 2020-11-12.

What interventions are being tested in trial NCT04497883?

The interventions under investigation include: Maribavir (400 mg) (DRUG), Maribavir (200 mg) (DRUG), Maribavir (800 mg) (DRUG).

Who is sponsoring clinical trial NCT04497883?

This trial is sponsored by Shire, which has 245 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.