Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants

Completed 32 enrolled Hoffmann-La Roche Shionogi · collab

RandomizedParallel-groupOpen-labelOther

Summary

This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.

Timeline

Start: 2019-06-19
Primary completion: 2019-07-11
Completion: 2019-07-11

Publications

Retout S, De Buck S, Jolivet S, Duval V, Cosson V. A Pharmacokinetics-Time to Alleviation of Symptoms Model to Support Extrapolation of Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B. Clin Pharmacol Ther. 2022 Aug;112(2):372-381. doi: 10.1002/cpt.2648. Epub 2022 Jun 10.
Liu Y, Retout S, Duval V, Jia J, Zou Y, Wang Y, Cosson V, Jolivet S, De Buck S. Pharmacokinetics, safety, and simulated efficacy of an influenza treatment, baloxavir marboxil, in Chinese individuals. Clin Transl Sci. 2022 May;15(5):1196-1203. doi: 10.1111/cts.13237. Epub 2022 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baloxavir Marboxil	Unknown	40 mg	Oral
Subject	Baloxavir Marboxil	Unknown	80 mg	Oral

Indications

No indication recorded.