Healthy Volunteers Clinical Trial
Official title:
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
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).
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.
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