Maribavir Food-Effect Study in Healthy Adults Participants
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.
Timeline
- Start
- 2022-05-25
- Primary completion
- 2022-07-02
- Completion
- 2022-07-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maribavir | Small molecule | 400 mg | Oral |
Indications
No indication recorded.