A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3004
Study Details
Study Description
Brief Summary
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3004
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 1 |
Detailed Description
A Phase 1, Randomized, Open-Label, Exploratory, Parallel, Pharmacokinetic Single Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) Long-Acting Injectable in Healthy Subjects
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Vivitrol Injection Vivitrol, Single Dose, IM injection |
Drug: Vivitrol Injectable Product
Naltrexone Long-Acting Injection
|
Experimental: IVL3004 (A mg) IM, Single Dose |
Drug: IVL3004
Naltrexone Long-Acting Injection
|
Experimental: IVL3004 (B mg) SC, Single Dose |
Drug: IVL3004
Naltrexone Long-Acting Injection
|
Outcome Measures
Primary Outcome Measures
- AUC [Pre-dose, up to Day 57]
Area under the concentration-time curve from time zero to Day 57
- Cmax [Pre-dose, up to Day 57]
The maximal observed concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adult male or female, ≥18 and ≤55 years of age, non-smokers
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BMI ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg for males and ≥50.0 kg for females.
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Healthy as defined by:
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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.
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The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
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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.
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Simultaneous use of hormonal contraceptives started at least 4 weeks prior to dosing and condom for the male partner.
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Simultaneous use of intrauterine device placed at least 4 weeks prior to dosing, and condom for the male partner.
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Sterile male partner (vasectomized since at least 3 months).
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Females of non-childbearing potential must be:
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Post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels ≥40 mIU/mL; or
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Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation) at least 3 months prior to dosing.
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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:
- 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.
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Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit.
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Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
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Male subjects must be willing not to donate sperm for 90 days after dosing.
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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:
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Any clinically significant abnormal finding at physical examination at screening.
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Clinically significant abnormal laboratory test results or positive serology test results for HIV, hepatitis B or hepatitis C virus at screening.
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Positive pregnancy test at screening or Day -1 or lactating female subject.
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Positive drug or alcohol screen at screening or Day -1.
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Any history of malignancy or neoplastic disease.
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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.
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ALT, AST or total bilirubin >1.5x ULN at screening or Day -1.
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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.
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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.
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History of significant bradycardia or AV block.
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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%).
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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.
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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):
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Depot injection or implant within 3 months prior to dosing;
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Any drug known to induce or inhibit hepatic metabolism within 30 days prior to dosing;
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Prescription medications within 14 days prior to dosing;
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Any vaccine, including COVID-19 vaccine, within 7 days prior to dosing;
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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.
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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;
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Anesthetic agents within 24 hours prior to dosing.
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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.
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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.
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Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Inventage Lab., Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IVL3004-001