Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT05382104
Brief 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.
Study:
NCT05382104
Study Brief:
Protocol Section:
NCT05382104