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NCT05918822 · ClinicalTrials.gov registry record · Phase 1
A Study of Maribavir Pediatric Formulation in Healthy Adult Participants
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05918822: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
NCT05918822 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05918822, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part. The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in the digestive tract compared to commercial tablet formulation and to check how a high-fat, high-calorie meal affects absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension. The main aim of Part 2 of this study is to assess the stomach acid reducing effect of multiple doses of rabeprazole on absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension. Each participant will stay in the study clinic from the day before the first treatment until the day after the last treatment.
Primary Outcome
Cmax was defined as maximum observed concentration of maribavir in plasma.
Conditions Studied
Interventions
- DRUG Rabeprazole
- DRUG Maribavir Commercial Tablet Formulation
- DRUG Maribavir Pediatric Powder-for-oral Suspension Formulation
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-07-25 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
What the finished NCT05918822 record still lists
NCT05918822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Rabeprazole is the first listed.
NCT05918822 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT05918822 about?
NCT05918822 is a clinical study titled "A Study of Maribavir Pediatric Formulation in Healthy Adult Participants". The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part. The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in the digestive tract compared to commercial tablet formulation and to che...
What is the current status of trial NCT05918822?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2023-07-25. Estimated completion is 2023-09-01.
What conditions does trial NCT05918822 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05918822?
The interventions under investigation include: Rabeprazole (DRUG), Maribavir Commercial Tablet Formulation (DRUG), Maribavir Pediatric Powder-for-oral Suspension Formulation (DRUG).
Who is sponsoring clinical trial NCT05918822?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05918822 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05918822's enrollment target sits among peer trials
32 171st of 283 higher than 99 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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