Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy

Opioid Use Disorder, Moderate Clinical Trial

Official title: A Phase 1, Single Dose, Open-label, Safety, Tolerability, and Pharmacokinetic Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy

Status Withdrawn

Clinical Trial Summary

A Phase 1, Single Dose, Open-label, Safety, Tolerability, and Pharmacokinetic Study of LYN-014 in Individuals with Opioid Use Disorder Who are Stable on Methadone Therapy

Clinical Trial Description

Lyndra Therapeutics is currently developing extended release (ER) capsules for weekly administration across therapeutic areas with certain medications for which consistent pharmacokinetics (PK) or enhanced adherence may translate to improved efficacy, and possibly better safety. LYN-014 ER capsules are intended to provide comparable levomethadone exposure to daily treatment with racemic methadone for people with opioid use disorder (OUD). Compared to daily methadone dosing, LYN-014 could provide greater accessibility to methadone therapy and reduce the time devoted to obtaining medication the number of visits to methadone clinics, and thus reduce the stigma associated with methadone treatment, improve the quality of life for patients, and reduce the potential for diversion. This single dose study will evaluate the safety, tolerability, and PK of LYN-014 in individuals with OUD who are stable on daily methadone treatment. Data from this study will inform formulation optimization and dose selection for further development. ;

Related Conditions & MeSH terms

• Opioid Use Disorder, Moderate
• Opioid-Related Disorders
• Substance-Related Disorders

• NCT number: NCT05251376
• Study type: Interventional
• Source: Lyndra Inc.
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 28, 2022
• Completion date: December 19, 2022