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NCT05382104 · ClinicalTrials.gov registry record · Phase 1
Maribavir Food-Effect Study in Healthy Adults Participants
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT05382104: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
NCT05382104 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 31 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05382104, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The main goals of this study are: 1) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a low-fat/low-calorie meal relative to administration under fasting conditions. 2) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a high-fat/high calorie meal relative to administration under fasting conditions. A single dose of 400 mg maribavir (commercial \[marketed\] tablet formulation) will be administered orally under 3 different feeding conditions: 1. Fasting (Treatment A), 2. Fed following a low-fat/low-calorie meal (Treatment B), and 3. Fed following a high fat/high-calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each single dose of investigational drug (ID) administration on Day 1 in each treatment cycle of 3 days. Pharmacokinetic samples will be collected at pre-dose and up to 36 hours post-dose in each treatment period. Safety and tolerability will be assessed throughout the study by Treatment Emergent Adverse Events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
Primary Outcome
Cmax of maribavir in plasma was reported using the non-compartmental analysis.
Conditions Studied
Interventions
- DRUG Maribavir
Study Locations (1)
Nebraska
- Celerion - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2022-07-02 |
| Phase | Phase 1 |
What the finished NCT05382104 record still lists
NCT05382104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Maribavir is the first listed.
NCT05382104 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05382104 about?
NCT05382104 is a clinical study titled "Maribavir Food-Effect Study in Healthy Adults Participants". The main goals of this study are: 1) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a low-fat/low-calorie meal relative to administration under fasting conditions. 2) To assess the relative bioavailability o...
What is the current status of trial NCT05382104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-05-25. Estimated completion is 2022-07-02.
What conditions does trial NCT05382104 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05382104?
The interventions under investigation include: Maribavir (DRUG).
Who is sponsoring clinical trial NCT05382104?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05382104 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05382104's enrollment target sits among peer trials
31 186th of 283 higher than 98 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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