Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 8:53 PM
Study NCT ID:
NCT04240158
Status:
TERMINATED
Last Update Posted:
2024-08-16
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IW-6463 Safety Study in Healthy Elderly Subjects
Sponsor:
Tisento Therapeutics
Organization:
Study Overview
Official Title:
Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Some subjects could not complete the second crossover period due to COVID-19-related site closure. The study was closed to allow analysis of all collected data.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.
Detailed Description:
Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CY6463 | OTHER | Cyclerion Therapeutics | View |