NCT03108755

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects

A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD). The purpose of the study is to evaluate the safety and tolerability of single and multiple ascending oral doses of ASP7713 in healthy non-Japanese (Part 1) and Japanese (Part 2) adult participants and non-Japanese elderly participants (Part 2). This study will also evaluate the pharmacokinetics of single and multiple ascending oral doses of ASP7713 in non-Japanese (Part1) and Japanese (Part 2) adult participants and non-Japanese elderly participants (Part 2) as well as the effect of a single and multiple oral dose of ASP7713 on the QT interval using Fridericia's Correction (QTcF). In addition, this study will evaluate a potential racial difference in safety, tolerability and pharmacokinetics of multiple oral doses of ASP7713 in healthy non-Japanese and Japanese adult participants (Part 2).

Detailed description

There will be a residential period for Parts 1 and 2. Part 1: Eligible participants will be residential for a single period of 5 days and 4 nights. Participants will be discharged on day 4 on the condition that all required assessments have been performed and that there are no medical reason for a longer stay in the clinical unit. Part 2: Eligible participants will be residential for a single period of 18 days and 17 nights. Participants will be discharged on day 17 on the condition that there are no medical reason for a longer stay in the clinical unit.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASP7713	oral
DRUG	Placebo	oral

Timeline

• Start date: 2017-05-23
• Primary completion: 2017-08-25
• Completion: 2017-08-25
• First posted: 2017-04-11
• Last updated: 2018-03-07

Locations

1 site across 1 country: United Kingdom