Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03108755
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2017-04-06
Brief Title:
A Study to Assess the Safety Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects
Sponsor:
Astellas Pharma Europe BV
Organization:
Astellas Pharma Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Fridericias 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
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 Fridericias 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004845-10 | EUDRACT_NUMBER | None | None |