A Phase 1 interventional study of Levomethadone HCl and Methadone in Opioid Use Disorder, Moderate, sponsored by Lyndra Inc.. Withdrawn. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Lyndra Inc. · Phase 1, Interventional, and Treatment
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
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →Lyndra Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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To be eligible to participate in the study, individuals must meet all the following inclusion criteria at Screening (and at other timepoints, where specified):
Male or female aged ≥18 and ≤59 years. Body mass index of ≥18 kg/m2 and ≤33 kg/m2. Moderate or severe OUD according to the DSM-5 criteria. Clinically stable (for at least 6 months) on oral daily methadone therapy at a dose of 80 to 100 mg and have been taking the same dose for at least 3 months, and are stably engaged in a methadone program, confirmed by a methadone provider and defined as (1) demonstrates evidence of regular attendance, (2) has not had problems with missed visits, and (3) consistently demonstrates drug-negative urine samples (except for cannabis).
Agree to provide the study site with contact information for the clinic where they get methadone and agree that a study physician can contact the clinician providing methadone to confirm appropriateness for study participation and to manage their transition into the study and from the study back to their opioid treatment program.
Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
Willing to comply with all protocol-specified procedures and availability for the duration of the study (e.g., participant is not aware of any emergent life-changes or potential family emergencies that would interfere with a 40+ day inpatient stay).
Exclusion Criteria:
To be eligible to participate in the study, individuals must not meet any of the following exclusion criteria at Screening (and at other timepoints, where specified):
a. Known strictures such as esophageal web, pyloric stenosis, small intestinal stricture, or individuals with high risk of stricture, ie, Crohn's disease b. Diagnosis of a condition known to elevate or lower gastric pH, eg, achlorhydria or hypochlorhydria c. Prior small or large bowel obstructions or varices d. Prior abdominal or upper GI surgery (prior uncomplicated laparoscopic procedures are permitted) e. History of dysphagia or aspiration in the last 5 years f. History of an esophageal motility disorder or undergoing treatment for a gastric motility disorder g. Significant history of diarrhea or constipation (non-methadone related) within 3 months of Screening h. Fewer than 3 bowel movements per week, on average i. Multiple episodes of abdominal pain in the prior 3 months j. Moderate or severe dysmenorrhea or menorrhagia (with use of pain medication) in the prior 3 months.
k. History of gastroparesis, rumination, autoimmune gastritis, H.pylori gastritis, or irritable bowel syndrome l. History compatible with acid reflux (heartburn, regurgitation, dysphagia, chest pain, water brash, globus sensation, odynophagia) m. Medical history compatible with Achlorhydria (i.e., history of autoimmune gastritis, pernicious anemia, H. plylori infection, partial gastrectomy).
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:
None = 0 no symptoms Mild = 1 awareness of symptom, but easily tolerated Moderate = 2 discomfort sufficient to cause interference with normal activities Severe = 3 incapacitating, with inability to perform normal activities.
Medical history or current diagnoses indicating the presence of any of the following conditions:
Use of the below in the 2 weeks before enrollment:
Clinically significant abnormal safety (e.g., physical examination, vital signs) or safety laboratory assessments at Screening, specifically:
The following specified patterns of substance use:
Women of childbearing potential and men, who are unwilling to use acceptable means of contraception through the EOS. For clarity, women who are at least 1 year post menopausal are considered not of childbearing potential and can be included in the study. Acceptable means of contraception include:
Extended-release levomethadone HCl 187 mg administered orally once on Day 8 of the study.
Drug: Levomethadone HCl · Drug: Methadone · Drug: Morphine Sulfate · Diagnostic Test: x-ray · Diagnostic Test: blood tests
One dose given orally on Day 8 of the study.
Also known as: extended-release levomethadone
Daily usual oral dose given on Day 1 and Day 2 of the study.
Also known as: oral methadone
Administered daily and as needed from Day 3 of the study until subject back on usual daily methadone dose.
Also known as: morphine
Abdominal x-rays done at specific study timepoints to assess the location of the LYN-014.
Also known as: abdominal x-ray
Done at specific timepoints throughout the study for PK (pharmacokinetics), genotyping and safety labs.
Also known as: Blood draws, lab tests
To evaluate the safety and tolerability of the LYN-014 dose when administered orally as a single dose
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (Cmin)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate Cmin (minimum concentration)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (Tmin)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate Tmin (Time at minimum concentration)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (Cmax)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate Cmax (maximum concentration)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (Tmax)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate Tmax (Time at maximum concentration)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (Kel)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate Kel (Elimination Rate Constant)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (AUC0-20)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate AUC0-20 (Area under the curve from 0-24 hours)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (AUC0-t)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate AUC0-t (Area under the curve from 0 to t hours)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (AUC0-∞t)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate AUC0-∞t (Area under the curve from 0 to infinity)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (C last)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate C last (Last measurable concentration)
Time frame: 52 days
To characterize the PK of levomethadone for LYN-014 (T last)
PK of levomethadone after oral administration of LYN-014, to include where possible and appropriate T last (Time at last measurable concentration)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Cmin)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Cmin (Minimum Concentration)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Tmin)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Tmin (Time at minimum concentration)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Cmax)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Cmax (Maximum concentration)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Tmax)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Tmax (Time at maximum concentration)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Kel)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Kel (Elimination Rate Constant)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (AUC0-24)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate AUC0-24 (Area under the curve from 0 to 24 hours)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (AUC0-t)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate AUC0-t (Area under the curve from 0 to t hours)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (AUC0-∞)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate AUC0-∞ (Area under the curve from 0 to infinity)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Clast)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Clast (Last measurable concentration)
Time frame: 52 days
To characterize the PK of methadone enantiomers after methadone dosing (Tlast)
PK of levomethadone and dextromethadone (S-enantiomer of methadone) after oral administration of methadone, to include where possible and appropriate Tlast (Time at last measurable concentration)
Time frame: 52 days
To characterize the PK of LYN 014 compared with that of daily methadone Cmax Extended Release to Cmax Immediate Release
Compare the PK ratio of Cmax (maximum concentration) ER (LYN-014) to Cmax (maximum concentration) IR (methadone).
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Cmin)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Cmin (minimum concentration)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Tmin)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Tmin (Time at minimum concentration)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Cmax)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Cmax (Maximum concentration)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Tmax)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Tmax (Time at maximum concentration)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Kel)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Kel (elimination rate constant)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (AUC0-24)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate AUC0-24 (Area under the curve from 0 to 24 hours)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (AUC0-t)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate AUC0-t (Area under the curve from 0 to t hours)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (AUC0-∞)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate AUC0-∞ (Area under the curve from 0 to infinity)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Clast)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Clast (last measurable concentration)
Time frame: 52 days
To evaluate possible conversion of Levomethadone to Dextromethadone (Tlast)
PK of dextromethadone after oral administration of LYN-014, to include where possible and appropriate Tlast (Time at last measurable concentration)
Time frame: 52 days
To assess gastrointestinal (GI) transit and exit properties of LYN 014.
GI transit and exit properties of LYN 014 assessed by X ray imaging and fecal recovery.
Time frame: 52 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Lyndra Inc.