Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480981
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-19
Brief Title:
Multiple Ascending Dose Noribogaine PKPD in Healthy Volunteers
Sponsor:
DemeRx NB
Organization:
DemeRx NB
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics Pharmacodynamics Safety and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-06
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 trial will be a randomised double-blind sequential-group multiple-dose placebo-controlled dose escalation trial to characterise the pharmacokinetics PK pharmacodynamics PD and safety of noribogaine in healthy adult participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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