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A Study to Investigate the Interaction Between TMP-301 and Cocaine.

NCT06648668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • Cocaine Use Disorder

Interventions

DRUG

TMP-301

Once daily \[QD\] × 14 days

DRUG

Placebo

Once daily \[QD\] × 14 days

Sponsors & Collaborators

  • Tempero Bio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-04
Primary Completion
2025-05-05
Completion
2025-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06648668 on ClinicalTrials.gov