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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: Completed Phase 1 study, sponsored by Shire.
NCT04497883 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax of maribavir in plasma were reported.
Interventions
- DRUG Maribavir (400 mg)
- DRUG Maribavir (200 mg)
- DRUG Maribavir (800 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2020-11-12 |
| Phase | Phase 1 |
What the finished NCT04497883 record still lists
NCT04497883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Maribavir (400 mg) is the first listed.
NCT04497883 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04497883's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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