Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy (NCT05251376) | Clinical Trial Compass
WithdrawnPhase 1
Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy
Stopped: Sponsor decision.
0Started 2022-02-28
Plain-language 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
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. History of moderate to severe Acid Reflux Disease or a score of ≥2 on the Acid Reflux Severity Scale (ARSS), indicating moderate to severe symptoms. The ARSS scale is as follows:
. Individuals with PILL 5 swallowing questionnaire score of 5 or greater.
. Medical history or current diagnoses indicating the presence of any of the following conditions:
. Presence of an uncontrolled, unstable, or clinically significant medical condition, mental impairment, or psychiatric disease (e.g., schizophrenia, bipolar, major depression, or borderline personality disorder) that could put the subject at risk because of participation in the study, interfere with the subject's ability to participate in the study or influence the interpretation of safety or PK evaluations
. History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure within 6 months of Screening
. Presence of Long QT Syndrome
. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening, in the opinion of the Sponsor/designee or Principal Investigator
. Known immunocompromised status, including individuals who have undergone organ transplantation, on immunosuppression for an immune mediated disease, or are positive for HIV
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of the LYN-014 dose when administered orally as a single dose
Timeframe: 52 days
2
To characterize the PK of levomethadone for LYN-014 (Cmin)
Timeframe: 52 days
3
To characterize the PK of levomethadone for LYN-014 (Tmin)
Timeframe: 52 days
4
To characterize the PK of levomethadone for LYN-014 (Cmax)
Timeframe: 52 days
5
To characterize the PK of levomethadone for LYN-014 (Tmax)
Timeframe: 52 days
6
To characterize the PK of levomethadone for LYN-014 (Kel)
Timeframe: 52 days
7
To characterize the PK of levomethadone for LYN-014 (AUC0-20)