Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-31 @ 2:20 PM
Study NCT ID:
NCT02564861
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Dose Study of D1971a in Healthy Volunteers
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 and Female Subjects
Status:
COMPLETED
Status Verified Date:
2017-04
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 and female subjects. Each participant receives lidocaine as a local anaesthetic before inserting the intravenous cannula.
Detailed Description:
Within strictly defined limits, the protocol permits the dose escalation committee to amend the dose escalation rules, doses proposed in the study protocol and to change the timing of or to add additional assessments following review of the safety, tolerability and plasma DS-1971a concentration data. The decisions to change the doses will be documented in the minutes of the dose escalation committee.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-002885-22 | EUDRACT_NUMBER | None | View |