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Tests treatment safety and results for Opioid Dependence
Official title A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
ClinicalTrials.gov ID: NCT05620940
What this study is testing
What is Vivitrol Injectable Product?
Vivitrol Injectable Product is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for opioid dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, men only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy adult male, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent...
- BMI ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg.
- Healthy as defined by:
- The absence of clinically significant illness, infection, or medical/surgical procedure within 4 weeks prior to dosing or planned inpatient surgery...
- The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological (including...
You likely can't join if
- Any clinically significant abnormal finding at physical examination at screening or Day -1.
- Clinically significant abnormal laboratory test results at screening or Day -1, or positive serology test results for human immunodeficiency virus...
- Is prone to skin rashes, irritation, or has a skin condition such as recurrent eczema that is likely to impact the injection site area or...
- Any history of malignancy or neoplastic disease.
- History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug, or to any excipient...
- ALT, AST, or total bilirubin \>1.5x upper limit of normal (ULN) at screening or Day -1.
See the full eligibility criteria
- Healthy adult male, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent per week, and willing to abstain from smoking during confinement at the...
- BMI ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg.
- Healthy as defined by:
- The absence of clinically significant illness, infection, or medical/surgical procedure 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 (including autoimmune), psychiatric, gastrointestinal, renal, hepatic, and metabolic...
- people 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...
- people who have had a vasectomy must be willing to use a condom until study exit.
- people who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
- people must be willing not to donate sperm for 90 days after dosing.
- Willing to undergo SC abdominal injection or IM ventral gluteal injection to allow for investigational drug administration.
- 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.
- Any clinically significant abnormal finding at physical examination at screening or Day -1.
- Clinically significant abnormal laboratory test results at screening or Day -1, or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.
- Is prone to skin rashes, irritation, or has a skin condition such as recurrent eczema that is likely to impact the injection site area or demonstrates any abnormal skin tissue in the proposed injection area, as...
- Any history of malignancy or neoplastic disease.
- History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug, or to any excipient present in the formulations.
- ALT, AST, or total bilirubin \>1.5x upper limit of normal (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 \ 140 mmHg, diastolic blood pressure \ 90 mmHg, or heart rate \ 100 bpm) at screening...
- 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...
- History of drug abuse within 1 year prior to screening or positive test for drugs of abuse (e.g., phencyclidine, opiates, benzodiazepines, barbiturates, amphetamines, methamphetamines, cocaine, and tetrahydrocannabinol)...
- Presence of any underlying physical or psychological (e.g., depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete...
- 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...
- Depot injection or implant within 3 months prior to dosing;
- Strong CYP inhibitors or inducers 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 (including topical and nasal formulations with active pharmaceutical ingredients) within 7 days prior to dosing, except for occasional use of acetaminophen/paracetamol (up to 2 g/day);
- 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...
- Anesthetic agents within 24 hours prior to dosing.
- Anticoagulant medications from 15 days prior to dosing to 6 weeks post- dose.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Herston, Queensland, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herston, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.