Maribavir Food-Effect Study in Healthy Adults Participants
Public ClinicalTrials.gov record NCT05382104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05382104
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2022
- Primary completion
- Jul 1, 2022
- Completion
- Jul 1, 2022
- Last update posted
- Feb 15, 2024
2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05382104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 15, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05382104 live on ClinicalTrials.gov.