TR08 - A Randomized, Double-Blind, Double-Dummy, Active-and Placebo-Controlled, Two-Part, 7-Way Crossover Study - Protocol

Sep 17, 2026

Confidential and proprietary study protocol for TR08 by Trevi Therapeutics, Inc., describing a randomized, double-blind, double-dummy, active- and placebo-controlled, two-part 7-way crossover evaluation of oral abuse potential of nalbuphine solution and extended-release intact tablets versus hydromorphone solution and placebo in nondependent, recreational opioid users. The document includes revision history, approvals, a structured Table of Contents, definitions, study purpose, responsibilities, analysis timings, objectives, subject selection criteria, study medication administration, procedures and flowchart, endpoints, and changes from planned analysis in the protocol, together with analysis populations and general statistical analysis aspects.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages65

Reading Time2 h 44 min

AccessFree to download

Revision History

Table of Contents

1. Glossary of Abbreviations

2. Purpose

2.1. Responsibilities

2.2. Timings of Analyses

3. Study Objectives

3.1. Exploratory Objectives

3.2. Brief Description

3.3. Subject Selection

3.3.1. Inclusion Criteria

3.3.2. Exclusion Criteria

3.3.3. Naloxone Challenge

3.4. Determination of Sample Size

3.5. Treatment Assignment & Blinding

3.6. Administration of Study Medication

3.7. Study Procedures and Flowchart

4. Endpoints

5. Change from Analysis Planned in Protocol

6. Analysis Populations

7. General Aspects for Statistical Analysis

| Sponsor Name:
Protocol Number and Title:
Protocol Version and Date:
Syneos Health Project Code:
Author:
SAP Version:
SAP Version Date: | Trevi Therapeutics, Inc.
TR08
A Randomized, Double-Blind, Double-Dummy, Active-and Placebo-Controlled, Two-Part, 7-Way Crossover Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets Relative to Hydromorphone Solution and Placebo in NonDependent, Recreational Opioid Users
3.0, 13-Aug-2018
2.0, 18-May-2018
1.0, 09-Apr-2018 1008910
Philippa Rook, Biostatistician II
Final 1.1
08-Aug-2019 | | --- | --- | Notice of Confidential and Proprietary Information: The information contained in this document is confidential belonging to Trevi Therapeutics, Inc. Acceptance of this document constitutes agreement by the recipient that no information contained herein will be published or disclosed without prior written authorization from an official of Trevi Therapeutics, Inc. However, this document may be disclosed to appropriate Institutional Review Board and Ethics Committees or duly authorized representatives of a national regulatory authority under the condition that they are requested to keep it confidential. In the event of an actual or suspected breach of this obligation, Syneos Health should be notified promptly. Revision History | Version \# | Date
(dd-mmm-yyyy) | Document Owner | Revision Summary | | --- | --- | --- | --- | | Draft Version 0.3 | 17Jul2018 | Philippa Rook | Initial release version – draft version 0.3 | | Draft Version 1.0 | 14Aug2018 | Philippa Rook | Updated draft version 1.0 | | Final Version 1.0 | 24Aug2018 | Philippa Rook | Final version 1.0 | | Final Version 1.1 | 08Aug2019 | Philippa Rook | Updated Final version 1.1 for the removal of Part B | I confirm that I have reviewed this document and agree with the content. | APPROVALS | | | | --- | --- | --- | | Syneos Health | | | | | | | | Lead Biostatistician
Philippa Rook
Biostatistician II | Date (dd-Mmm-yyyy) | | | Senior Reviewing Biostatistician
Georgia Gourgioti
Manager, Biostatistics | Date (dd-Mmm-yyyy) | | | Lead Statistical Programmer
Rohit Srivastava
Associate Director, Statistical Programming | | Date (dd-Mmm-yyyy) | | Hiren Mehta
Senior Pharmacokineticist, Pharmacokinetics | | Date (dd-Mmm-yyyy) | | APPROVALS | | --- | | Trevi Therapeutics, Inc. | | | | Thomas Sciascia, MD Date (dd-Mmm-yyyy)
Chief Medical Officer | TABLE OF CONTENTS CONTENTS REVISION HISTORY .................................................................................................2 TABLE OF CONTENTS ............................................................................................. 5 1. GLOSSARY OF ABBREVIATIONS.................................................................9 2. PURPOSE...................................................................................................... 12 2.1. Responsibilities ................................................................................................................. 12 2.2. Timings of Analyses .......................................................................................................... 12 3. STUDY OBJECTIVES ................................................................................... 13 3.1. Exploratory Objectives ...................................................................................................... 13 3.2. Brief Description ................................................................................................................ 13 3.3. Subject Selection ............................................................................................................... 15 3.3.1. Inclusion Criteria ......................................................................................................... 15 3.3.2. Exclusion Criteria .......................................

FAQs

What is the TR08 study designed to evaluate?

TR08 evaluates the oral abuse potential of nalbuphine solution and extended-release intact tablets relative to hydromorphone solution and placebo in nondependent, recreational opioid users.

What study design features are specified in the protocol?

The protocol specifies a randomized, double-blind, double-dummy, active- and placebo-controlled, two-part, 7-way crossover design.

Where are study purpose, responsibilities, and analysis timing described?

These are covered under the Purpose section, including Responsibilities and Timings of Analyses in the Table of Contents.

Sep 17, 2026

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