NCT02108548

A Study to Assess the Safety and Tolerability, Including Gastrointestinal Safety, Pharmacokinetics and Pharmacodynamics of ASP7657 in Caucasian Healthy Male and Female Subjects

A Phase 1 Ascending Single and Multiple Oral Dose Study to Assess the Safety and Tolerability, Including Gastrointestinal Safety, Pharmacokinetics and Pharmacodynamics of ASP7657 in Caucasian Healthy Male and Female Subjects, Including a Food Effect Cohort

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of ASP7657 in healthy subjects.

Detailed description

Subjects are healthy males aged 18 to 55 years of age (inclusive) (Parts 1 and 2, young cohorts) or the subject is an elderly healthy male or female subject aged 65 years or more (Part 2, elderly cohort).

Conditions

• Pharmacokinetics of ASP7657
• Pharmacodynamics of ASP7657
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP7657	oral
DRUG	Placebo	oral
DRUG	naproxen	oral

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-04-09
• Last updated: 2015-03-27

Locations

1 site across 1 country: United Kingdom