Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517563
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Study to Assess the Effects of VMX-C001 in Combination With an Oral FXa DOAC on the Efficacy of Unfractionated Heparin and of VMX-C001 Alone on the Efficacy of Low Molecular Weight Heparin in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single centre open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin UFH and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin LMWH in healthy subjects conducted in two parts
UFH cohort Subjects will be administered 2 single doses of 5000 IU UFH iv on Day 1 and Day 5 oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5 and one single dose of 170 mg VMX-C001 iv on Day 5
LMWH cohort Subjects will be administered 2 single doses of 40 mg Enoxaparin sc on Day 1 and Day 4 and one single dose of 170 mg VMX-C001 iv on Day 4
UFH cohort Subjects will be administered 2 single doses of 5000 IU UFH iv on Day 1 and Day 5 oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5 and one single dose of 170 mg VMX-C001 iv on Day 5
LMWH cohort Subjects will be administered 2 single doses of 40 mg Enoxaparin sc on Day 1 and Day 4 and one single dose of 170 mg VMX-C001 iv on Day 4
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None