A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects

USWM, LLC (dba US WorldMeds)1 site in 1 country16 target enrollmentJune 1, 2025

ConditionsOpioid Withdrawal (Disorder)Opioid Use Disorder

InterventionsLUCEMYRA (lofexidine) tablets

DrugsLUCEMYRA (lofexidine) tablets

Overview

Phase: Phase 1
Intervention: LUCEMYRA (lofexidine) tablets
Conditions: Opioid Withdrawal (Disorder)
Sponsor: USWM, LLC (dba US WorldMeds)
Enrollment: 16
Locations: 1
Primary Endpoint: Peak and trough plasma concentrations following daily LUCEMYRA doses during clinic confinement
Status: Withdrawn
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.

Detailed Description

This is a Phase 1, Open-label, PK, safety, and tolerability study of LUCEMYRA in adolescents aged ≥12 to \<18 years abruptly discontinuing opioid use. The objectives of the study are to evaluate the PK parameters, as well as safety and tolerability. The effectiveness of LUCEMYRA on the signs and symptoms of acute opioid withdrawal will also be evaluated.

Registry

clinicaltrials.gov

Start Date

June 1, 2025

End Date

February 1, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

USWM, LLC (dba US WorldMeds)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written minor assent obtained either in English or Spanish, as applicable, in accordance with local laws and Institutional Review Board (IRB) requirements. Additionally, written informed consent obtained from the participant's parent or LAR/guardian(s) in accordance with local laws and IRB requirements.
•Participant is willing and able to comply with scheduled visits, study dosing, laboratory tests, and other study procedures.
•Participant can swallow tablets the same size as LUCEMYRA.
•Adolescent male or female participants ≥12 years and \<18 years of age (at the time of study entry).
•Minimum weight ≥30 kg.
•Female participants of childbearing potential must agree to practice a medically acceptable method of contraception (e.g., intrauterine device, hormonal contraception started at least one full cycle before study enrollment or barrier method in conjunction with spermicide) for the duration of the study (including 2 months after study completion). With approval by the Investigator, participants' parents or legal guardians may select abstinence as a form of birth control if deemed more appropriate. For the purposes of this study, all females are considered of childbearing potential unless they are confirmed by the Investigator to be premenarchal, biologically sterile, or surgically sterile (e.g., hysterectomy, bilateral oophorectomy, tubal ligation).
•All female participants, regardless of childbearing potential, must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Screening and prior to dosing on Day
•History of opiate use as confirmed by diagnosis of OUD according to the diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); documentation of opioid use in the participant's medical record; or self-report of opioid use by participant and seeking treatment for OUD.
•Reported use of fentanyl, heroin, morphine, or any opioid with a half-life similar to heroin or morphine such as Vicodin®, Lortab®, Lorcet®, Percocet®, Percodan®, Tylox®, or hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected, or swallowed after chewing) for at least 21 of the past 30 days and use within 2 days of admittance to the inpatient clinic.
•Urine toxicology screen positive for opioids.

Exclusion Criteria

•Known or suspected pregnancy, planned pregnancy, or lactation.
•Treatment with an investigational drug, device, or biological agent within 30 days prior to Screening, or during LUCEMYRA administration in this study.
•Any medical illness, condition, or clinical finding that, in the opinion of the Investigator and/or the Sponsor, would put the participant at undue risk or interfere with the participant's ability to complete the study.
•Any anticipated or scheduled surgery during the study period.
•Major surgery within 30 days before Screening.
•Have clinically significant abnormal laboratory values as determined by the Investigator.
•Abnormal cardiovascular exam at Screening, including any of the following:
•Clinically significant abnormal ECG (e.g., second or third-degree heart block, uncontrolled arrhythmia)
•QT with Fridericia's correction (QTcF) of ≥450 msec
•History of QT interval prolongation Note: if the QTcF interval meets the above criteria, the value may be confirmed by repeating the measurement (twice, if necessary). If 2 of 3 values meet the above criteria, the participant will be excluded from participation.

Arms & Interventions

LUCEMYRA: 0.36 mg

The initial LUCEMYRA dose for this study will be based on weight. Participants who weigh ≥30 to \<45 kg will receive two 0.18 mg tablets (0.36 mg) QID.

Intervention: LUCEMYRA (lofexidine) tablets

LUCEMYRA: 0.54 mg

The initial LUCEMYRA dose for this study will be based on weight. Participants who weigh ≥45 kg will receive three 0.18 mg tablets (0.54 mg) QID.

Intervention: LUCEMYRA (lofexidine) tablets

Outcomes

Primary Outcomes

Peak and trough plasma concentrations following daily LUCEMYRA doses during clinic confinement

Time Frame: Day 1 (2, 3, 4, 5, 9 hours post dose), Days 2-4 (pre-dose and 4 hours post first daily dose), Taper Days 1-4 (pre-dose and 4 hours post first daily dose), Day of Discharge

Secondary Outcomes

Estimation of apparent clearance and apparent volume of distribution for lofexidine and evaluation of possible covariates affecting PK(Day 1 post dose, Lucemyra fixed dosing days (4-8 days), Lucemyra Tapering days (4 days), discharge (1 day))
Treatment-emergent adverse events (TEAEs)(Day 1 post dose, Lucemyra fixed dosing days (4-8 days), Lucemyra Tapering days (4 days), safety monitoring (2.5 days), discharge (1 day), 30 day follow up)
Vital signs: Heart Rate(Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14))
Vital Signs: Systolic blood pressure(Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14))
Vital Signs: Diastolic blood pressure(Day -7 to -1, Dosing days (1 day up to 12 days), post last Lucemyra dose (Days 9 up to 14))
Electrocardiograms (ECGs) QT Interval(Day -7 to -1, Day 3)
Columbia-Suicide Severity Rating Scale (C-SSRS)(Day -7 to -1, Day 1, 2.5 days after last dose (discharge))
Number of participants with abnormal laboratory test results (hematology)(Day -7 to -1, 2.5 days after last dose (discharge))
Number of participants with abnormal laboratory test results (clinical chemistry)(Day -7 to -1, 2.5 days after last dose (discharge))