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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: ASP8477; Omeprazole

Criteria

Inclusion Criteria:

• Healthy young (<65 years of age at first planned dose) postmenopausal female (Parts I, III, and IV).

• Healthy young vasectomized male subject aged 18-55 years inclusive (Part II).

• Body Mass index between 18.5 and 30.0 kg/m2 inclusive.

Exclusion Criteria:

• Known or suspected hypersensitivity to ASP8477 or any of the components of the formulations used.

• Any of the liver function tests above the upper limit of normal.

• A family history of psychiatric disorders.

• Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.

• Use of xanthine-containing beverages within 48 hours before admission.