Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05845398
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2023-04-26
Brief Title:
Phase 1b Study of DCR-AUD in Healthy Volunteers
Sponsor:
Dicerna Pharmaceuticals Inc a Novo Nordisk company
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Phase 1b Double-blind Placebo-controlled Repeat-dose Safety Tolerability Pharmacokinetic and Pharmacodynamic Study of DCR-AUD in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to test the safety tolerability pharmacokinetics PK and pharmacodynamics PD of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers
The main questions it aims to answer are
Are repeat doses of DCR-AUD safe and well-tolerated in healthy adults who are social drinkers
How does the drug behave inside the human body and how it is removed from the human body
What are the symptoms the drug may cause with alcohol consumption
Participants will
Receive multiple doses of DCR-AUD
Have assessment visits through Week 24
Participate in up to 10 Ethanol Interaction Assessments EIAs to see how the body is affected by DCR-AUD
Researchers will compare the groups of participates who receive study drug with the group of participants who receive placebo to see if the study drug is safe and tolerable and whether the study drug has any real effect
The main questions it aims to answer are
Are repeat doses of DCR-AUD safe and well-tolerated in healthy adults who are social drinkers
How does the drug behave inside the human body and how it is removed from the human body
What are the symptoms the drug may cause with alcohol consumption
Participants will
Receive multiple doses of DCR-AUD
Have assessment visits through Week 24
Participate in up to 10 Ethanol Interaction Assessments EIAs to see how the body is affected by DCR-AUD
Researchers will compare the groups of participates who receive study drug with the group of participants who receive placebo to see if the study drug is safe and tolerable and whether the study drug has any real effect
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