Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576843
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
INDV-6001 Multiple-Dose Pharmacokinetic Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multicentre Study to Evaluate the Pharmacokinetics Safety and Tolerability of Repeated Doses of INDV-6001 in Adults with Moderate to Severe Opioid Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The current study will evaluate the pharmacokinetics safety and tolerability of INDV-6001 following multiple doses in participants with opioid use disorder in order to select optimum dosing regimens for future studies Prior to receiving INDV-6001 participants will be stabilised on 12-16 mg of transmucosal BUP SUBOXONE or will transition from a monthly maintenance dose of subcutaneous extended-release BUP SUBLOCADE This study will also evaluate the use of alternative injection sites thigh back of upper arm which may be desirable in this patient population for the anticipated extended durations of treatment
Detailed Description:
There are 6 cohorts testing varying dose strengths and frequencies of INDV-6001
Cohorts 1-4 are suitable for participants that are not receiving long-acting treatment for OUD
Cohorts 5-6 are suitable for participants currently receiving SUBLOCADE
There are 3 periods within this study
Screening Period from the screening visit until prior to the first SUBOXONE or SUBLOCADE dose as a part of this study
Pre-Investigational Medicinal Product IMP Period from the first SUBOXONE or SUBLOCADE dose as a part of this study until prior to the first INDV-6001 dose
IMP Period from the first INDV-6001 dose until the end of the study
Cohorts 1-4 are suitable for participants that are not receiving long-acting treatment for OUD
Cohorts 5-6 are suitable for participants currently receiving SUBLOCADE
There are 3 periods within this study
Screening Period from the screening visit until prior to the first SUBOXONE or SUBLOCADE dose as a part of this study
Pre-Investigational Medicinal Product IMP Period from the first SUBOXONE or SUBLOCADE dose as a part of this study until prior to the first INDV-6001 dose
IMP Period from the first INDV-6001 dose until the end of the study
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