A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects

Phase 1 Completed 26 enrolled Astellas Pharma Europe B.V.

RandomizedCrossoverDouble-blindBasic science

Summary

The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects.

Timeline

Start: 2012-08
Primary completion: 2012-12
Completion: 2012-12

Publications

Takizawa M, Cerneus D, Michon I, Rijnders S, Meijer J, Someya A, Sato Y. Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels. Adv Ther. 2020 Sep;37(9):3967-3984. doi: 10.1007/s12325-020-01451-6. Epub 2020 Jul 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP3652	Unknown	600 mg	Oral
Subject	ASP3652	Unknown	1800 mg	Oral

Indications

No indication recorded.