drugset / Trial / NCT02243657

A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652

NCT02243657

Phase 1 Completed 101 enrolled Astellas Pharma Europe B.V.
RandomizedSingle-groupTriple-blindBasic science

Summary

The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated. The study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo. Part 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo. For both parts of the study, the subjects stay in the clinic for one period of 18 days.

Timeline

Start
2009-05
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP3652 Unknown Oral

Indications

No indication recorded.