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A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of of ASP2205

Healthy Subjects Clinical Trial

Official title:
A Phase 1 Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of ASP2205

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP2205 in healthy young male and female subjects. This study will also evaluate the safety and tolerability of multiple ascending oral doses of ASP2205 in healthy young and elderly female subjects.

Clinical Trial Description

Part 1 is a single ascending dose investigator-blinded study in healthy young male and female subjects. Six doses of ASP2205 or matching placebo will be given to separate cohorts consisting of 8 subjects each, with 6 subjects receiving ASP2205 and 2 subjects receiving matching placebo. ASP2205 or matching placebo will be given as a single oral dose under fasted conditions.

The effect of a high-calorie high-fat meal (breakfast) on the safety, tolerability and pharmacokinetics of a single oral dose of ASP2205 will be evaluated in a separate cohort of 8 subjects in an open-label manner.

Part 2 is a multiple ascending dose subject- and investigator-blinded study comprising 3 cohorts with each 12 healthy young (aged 25 to 55 years) female subjects and 1 cohort with 12 healthy elderly (aged 65 years or older) female subjects who will receive ASP2205 or matching placebo. Nine subjects in each cohort will be treated with ASP2205 and 3 subjects will be treated with matching placebo (ratio 3:1). ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02314793
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 1
Start date November 2014
Completion date October 2015
View Details
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