NCT02314793

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Healthy Subjects
• Pharmacokinetics of ASP2205

Interventions

Type	Name	Description
DRUG	ASP2205	oral
DRUG	Placebo	oral

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-12-11
• Last updated: 2016-06-21

Locations

1 site across 1 country: United Kingdom