11.25.24 BI sample.pptx

A Phase 1b multi-center, randomized, double-blind, parallel group, placebo-controlled trial to evaluate the effects on impulsivity, pharmacokinetics, safety, and tolerability of oral BI 12345678 in patients with opioid use disorder taking background XXXYYY treatment

Trial 1234-5678

Assessments

Introduction

Investigational Plan

Trial Design

Objectives and Endpoints

Agenda

1427-0015 - Clinical Trial Protocol Overview v1

Investigational Plan

Assessments

Trial Design

Objectives and Endpoints

Introduction

• Opioid Use Disorder (OUD) is a chronic, relapsing illness that significantly impacts lives of patients.
• As per cdc.gov the number of opioid-related deaths has been rising continuously since 1999. The number of people who died from a drug overdose in 2021 was over six times the number in 1999. Over 75% of the nearly 107,000 drug overdose deaths in 2022 involved an opioid.
• Patients with Opioid Use Disorder (OUD) are said to be highly impulsive. High impulsivity is associated with increased risk for addiction, relapse, functional impairment, and decreased quality of life
• There are no current medications targeting impulsivity in opioid use disorder (OUD). Therefore, there remains a significant unmet medical need and medications that improve impulsivity and reduce impulsive relapse would constitute a significant medical advance.
• This study aims to test BI 123456 as a treatment for XXXYYY in OUD patients to address this unmet need.

Medical Background

1427-0015- Clinical Trial Protocol Overview v1

Investigational Plan

Assessments

Trial Design

Objectives and Endpoints

Primary Objectives and Endpoints

1427-0015 - Clinical Trial Protocol Overview v1

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