drugset / Trial / NCT02220777

A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males

NCT02220777 ↗

Phase 1 Completed 72 enrolled Astellas Pharma Europe B.V.
RandomizedCrossoverDouble-blindBasic science

Summary

This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects. Part II is similar to part I except that the study is conducted in young, vasectomized males. Part III assesses the effect of food (fed or fasted conditions) on ASP8477 in postmenopausal subjects. Part IV assesses the drug-drug interaction between ASP8477 and omeprazole in postmenopausal subjects.

Timeline

Start
2010-11
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP8477 Small molecule — Oral
Subject Omeprazole Other / unclassified — Oral

Indications

No indication recorded.