A Study of Maribavir Pediatric Formulation in Healthy Adult Participants

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.

Timeline

Start

2023-07-25

Primary completion

2023-08-25

Completion

2023-09-01

Publications

• Campagne O, Ilic K, Gabriel A, Sueda K, Ye R, Zhang F, Xu P, Ko HH, Sun K. A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Volunteers to Evaluate the Bioavailability of the Maribavir Powder for Oral Suspension, as Well as Food Effect and Impact of Rabeprazole. Clin Pharmacol Drug Dev. 2025 Feb;14(2):133-143. doi: 10.1002/cpdd.1493. Epub 2024 Dec 22.

Drugs

Indications

No indication recorded.