Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT06648668
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2024-10-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Interaction Between TMP-301 and Cocaine.
Sponsor:
Tempero Bio, Inc.
Organization:
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:
COMPLETED
Status Verified Date:
2025-05
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 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:
True
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?: