A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3004

Study Overview
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Brief Summary
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A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3004

Detailed Description
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A Phase 1, Randomized, Open-Label, Exploratory, Parallel, Pharmacokinetic Single Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) Long-Acting Injectable in Healthy Subjects

Official Title
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A Phase 1, Randomized, Open-Label, Exploratory, Parallel, Pharmacokinetic Single Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) LAI in Healthy Subjects

Conditions
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Opioid Dependence, Alcohol Dependence

Intervention / Treatment
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* Drug: Vivitrol Injectable Product
* Drug: IVL3004


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male or female, ≥18 and ≤55 years of age, non-smokers BMI ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg for males and ≥50.0 kg for females. Healthy as defined by: The absence of clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks prior to dosing, or planned inpatient surgery (including dental surgery) or hospitalization during the study period. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 57 days after dosing for subjects in all cohorts. Simultaneous use of hormonal contraceptives started at least 4 weeks prior to dosing and condom for the male partner. Simultaneous use of intrauterine device placed at least 4 weeks prior to dosing, and condom for the male partner. Sterile male partner (vasectomized since at least 3 months). Females of non-childbearing potential must be: Post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels ≥40 mIU/mL; or Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation) at least 3 months prior to dosing. Male subjects who are not vasectomized for at least 3 months prior to dosing, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from dosing and for 90 days after dosing: a. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used for at least 4 weeks or intrauterine device placed for at least 4 weeks prior to sexual intercourse. Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit. Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle. Male subjects must be willing not to donate sperm for 90 days after dosing. Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol specific study procedures. Exclusion Criteria: Any clinically significant abnormal finding at physical examination at screening. Clinically significant abnormal laboratory test results or positive serology test results for HIV, hepatitis B or hepatitis C virus at screening. Positive pregnancy test at screening or Day -1 or lactating female subject. Positive drug or alcohol screen at screening or Day -1. Any history of malignancy or neoplastic disease. History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to naltrexone or other related drugs, or to any excipient present in the formulation for any study drug. ALT, AST or total bilirubin >1.5x ULN at screening or Day -1. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 as calculated by the 2021 Chronic Kidney Disease-Epidemiology (CKD-EPI) equation at screening or Day -1. Clinically significant ECG abnormalities (QTc >450 ms or PR interval >220 ms) or vital sign abnormalities (systolic blood pressure <90 or >140 mmHg, diastolic blood pressure <40 or >90 mmHg, or heart rate <50 or >100 bpm) at screening or Day -1. History of significant bradycardia or AV block. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 units of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of spirit 40%). History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) or hard drugs (such as cocaine, PCP, crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 month, or use of codeine within 3 months prior to screening. Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption): Depot injection or implant within 3 months prior to dosing; Any drug known to induce or inhibit hepatic metabolism within 30 days prior to dosing; Prescription medications within 14 days prior to dosing; Any vaccine, including COVID-19 vaccine, within 7 days prior to dosing; OTC medications within 7 days prior to dosing, except for occasional use of acetaminophen/paracetamol (up to 2 g/day), and topical formulations without significant systemic absorption. Natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to dosing; Anesthetic agents within 24 hours prior to dosing. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to dosing. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vivitrol Injection<br>Vivitrol, Single Dose, IM injection | Drug: Vivitrol Injectable Product<br>* Naltrexone Long-Acting Injection<br>|
| Experimental: IVL3004 (A mg)<br>IM, Single Dose | Drug: IVL3004<br>* Naltrexone Long-Acting Injection<br>|
| Experimental: IVL3004 (B mg)<br>SC, Single Dose | Drug: IVL3004<br>* Naltrexone Long-Acting Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under the concentration-time curve from time zero to Day 57 | Pre-dose, up to Day 57 | 
| Cmax | The maximal observed concentration | Pre-dose, up to Day 57 |