Title
Pharmacokinetics and Safety Evaluation of Maribavir in Healthy Japanese and Matched White Participants: A Phase I, Open-Label Study
Author
Song, Ivy, Ben Suttle, Jingyang Wu, and Katarina Ilic
Year
2023
Journal
Clinical Pharmacology in Drug Development
Abstract
This phase I study compared pharmacokinetics and safety of maribavir in Japanese and White participants, and evaluated dose proportionality in Japanese participants. Under fasting conditions, 12 healthy adult participants of Japanese descent and 12 matched White participants received a single 400-mg dose of maribavir. Japanese participants received 2 further doses of maribavir: 200 mg and 800 mg, or 800 mg and 200 mg, separated by a ≥72-hour washout period. Serial blood samples were collected up to 24 hours after dosing for maximum plasma concentration increased less than dose proportionally. Seven participants reported treatment-emergent adverse events (TEAEs Japanese participants, 400 mg: 2 [16.7%], 200 mg: 1 [8.3%] White participants, 400 mg: 4 [33.3%]), all mild and most commonly dysgeusia. No serious TEAEs or TEAEs leading to discontinuation were reported. This study demonstrated higher maribavir systemic exposure in Japanese than White participants and similar safety outcomes. This difference in exposure is not considered clinically important and its significance remains to be determined. pharmacokinetic assessments. Following the 400-mg dose, the geometric mean ratios (90% confidence interval) of Japanese versus White participants were 110% (91.7%–133%) for maximum plasma concentration, 122% (96.8%–155%) for area under the plasma concentration–time curve (AUC) from time of dosing to the last measurable concentration, and 125% (98.0%–160%) for AUC extrapolated to infinity. In Japanese participants, maribavir AUC extrapolated to infinity and AUC from time of dosing to the last measurable concentration increased in a dose-proportional fashion over 200–800 mg
Instrument
LC-900
Keywords
Maribavir,Cytomegalovirus