Maribavir Food-Effect Study in Healthy Adults Participants
Status:
Not yet recruiting
Trial end date:
2022-06-15
Target enrollment:
Participant gender:
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.