Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648668
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Cocaine Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Participant- and Investigator-blinded Placebo-controlled Parallel-group Study to Assess the Safety Tolerability and Pharmacokinetics of Oral TMP-301 Given Concurrently With Cocaine
Status:
NOT_YET_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:
This will be a randomized double-blind placebo-controlled parallel-group study to assess the safety tolerability pharmacokinetics and pharmacodynamics of oral TMP-301 given concurrently with cocaine The study will consist of 4 phases Screening Baseline Treatment and Follow-up
Detailed Description:
This will be a randomized double-blind placebo-controlled parallel-group study to assess the safety tolerability PK and PD of oral TMP-301 given concurrently with cocaine The study will consist of 4 phases Screening Baseline Treatment and Follow-up The Screening Phase will be completed as an outpatient visit within 24 days of the Baseline Phase and will consist of a standard medical screen Within 24 days of a standard medical screening eligible participants will return to the clinical site as inpatients to complete the Baseline Phase All participants will remain in-clinic for the duration of the 7-day Treatment Phase Following confirmation of eligibility participants will be randomized to one of two treatment groups either TMP-301 or A safety follow-up visit will be conducted on Day 23
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