Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-04 @ 10:20 PM
Study NCT ID:
NCT02348333
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2015-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeated Dose Phase I Study of FYU-981
Sponsor:
Fuji Yakuhin Co., Ltd.
Organization:
Study Overview
Official Title:
Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
Status:
COMPLETED
Status Verified Date:
2015-01
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 safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.
Detailed Description:
None
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?: