NCT05251376

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

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lyndra Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Opioid Use Disorder, Moderate

Interventions

Type	Name	Description
DRUG	Levomethadone HCl	One dose given orally on Day 8 of the study.
DRUG	Methadone	Daily usual oral dose given on Day 1 and Day 2 of the study.
DRUG	Morphine Sulfate	Administered daily and as needed from Day 3 of the study until subject back on usual daily methadone dose.
DIAGNOSTIC_TEST	x-ray	Abdominal x-rays done at specific study timepoints to assess the location of the LYN-014.
DIAGNOSTIC_TEST	blood tests	Done at specific timepoints throughout the study for PK (pharmacokinetics), genotyping and safety labs.

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2022-02-22
• Last updated: 2023-01-19

Regulatory

• FDA-regulated drug study