Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-04-16 @ 4:56 AM
Study NCT ID:
NCT02190058
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Dose Study of DS-1971a
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A PHASE I, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO ASSESS SAFETY, TOLERABILITY AND PHARMACOKINETICS OF DS-1971A IN HEALTHY MALE SUBJECTS
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:
This is a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male subjects.
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?: