Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185764
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-12-15
Brief Title:
A Phase 12 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 DM1
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Vertex Pharmaceuticals Incorporated
Study Overview
Official Title:
A Phase 12 Randomized Double-blind Placebo-controlled Single- and Multiple-dose Escalation Study Evaluating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of VX-670 in Adult Subjects With Myotonic Dystrophy Type 1
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Galileo
Brief Summary:
The purpose of the study is to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of VX-670 at different single and multiple doses in participants with DM1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506028-10-00 | OTHER | EUCT Number | None |