Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

Phase 1 Completed 36 enrolled Astellas Pharma Inc

RandomizedParallel-groupDouble-blindBasic science

Summary

The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.

Timeline

Start: 2006-07
Primary completion: 2006-10
Completion: 2006-10

Publications

Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amenamevir	Small molecule	300 mg	Oral
Subject	Amenamevir	Small molecule	600 mg	Oral

Indications

No indication recorded.