Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT01884558
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
Sponsor:
Astellas Pharma Global Development, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
Status:
COMPLETED
Status Verified Date:
2013-06
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:
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will be assessed alone and in combination with metformin.
Detailed Description:
Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10.
A follow-up telephone call will be made on Day 16 to check on health status.
A follow-up telephone call will be made on Day 16 to check on health status.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: