Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216132
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-08
First Post:
2023-12-27
Brief Title:
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
Sponsor:
Drug Delivery Company LLC DBA Akyso Pharmaceuticals
Organization:
Drug Delivery Company LLC DBA Akyso Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Placebo-controlled Single-Ascending-Dose Study of BIOPIN 6 in Healthy Adults
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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 purpose of this study is to evaluate the safety and blood levels of a medicine naltrexone contained within an implant in healthy volunteers age 18 to 65 years To do this the implant containing the drug will be inserted under the skin left in place for 3 months and then removed
Detailed Description:
Naltrexone NTX is a medication that helps people with opioid and alcohol dependence It works by blocking the effects of opioids like heroin in the body In the United States participants can get NTX in two forms a pill participants take once a day Revia and a shot participants get once a month Vivitrol Even though NTX is good at stopping the effects of opioids some people find it hard to take it regularly Thats why scientists are looking into making a new version of NTX that participants only need to take once a month This could make it easier for people with opioid use problems to stick with their treatment plan
The device being tried out in this research is called BIOPIN-6 Its made to stay in the body for more than a month The study will go on for three months and aims to check if the BIOPIN-6 is safe and how much medicine it releases into the blood Once the three months are up the device will be taken out
The device being tried out in this research is called BIOPIN-6 Its made to stay in the body for more than a month The study will go on for three months and aims to check if the BIOPIN-6 is safe and how much medicine it releases into the blood Once the three months are up the device will be taken out
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 |
|---|---|---|---|
| 5UG3DA048338-02 | NIH | None | httpsreporternihgovquickSearch5UG3DA048338-02 |