A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses

NCT01998646 ↗

Phase 1 Completed 130 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupQuadruple-blind

Summary

The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This study will also explore the effect of food on the PK of ASP4058.The food-effect crossover group was open-label treatment with no placebo control.

Timeline

Start: 2010-08
Primary completion: 2012-07
Completion: 2012-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP4058	Small molecule	—	Oral

Indications

No indication recorded.