Opioid DependencePhase 1NCT05620940
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
A Phase 1 study testing Vivitrol Injectable Product, IVL3004 and IVL4002 in people with Opioid Dependence and Alcohol Dependence, run by Inventage Lab., Inc. at 1 site in Australia.
Trial summary
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Alcohol Dependence, Multiple Sclerosis
- What is being tested?
- Vivitrol Injectable Product, IVL3004 and IVL4002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Sep 2024to 30 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 clinical site).
- 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 disease.
- 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:
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- 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 dosing.
- Subjects who have had a vasectomy must be willing to use a condom until study exit.
- Subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
- Subjects 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.
Who cannot join
- 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 determined by the Investigator.
- 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.
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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.
- 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 <40 or >100 bpm) at screening or Day -1.
- 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%), or positive alcohol test at screening or Day -1.
- 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) at screening or Day -1.
- 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 the study per protocol. Mild depression and anxiety that has been resolved at least 6 months prior to screening is accepted.
- 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:
- 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 sports) within 7 days prior to dosing;
- 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network
Herston, Queensland, 4006
Michael Wong, Dr., +61 7 3707 2790, m.wong@nucleusnetwork.com.au
About this study
Official title: A PHASE 1, OPEN-LABEL, EXPLORATORY, FIXED-SEQUENCE, PHARMACOKINETIC SINGLE ASCENDING DOSE STUDY OF IVL3004 VERSUS VIVITROL® (NALTREXONE) LONG-ACTING INJECTABLE (LAI) AND IVL4002 IN HEALTHY SUBJECTS
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Read the detailed description
A Phase 1, Open-Label, Exploratory, Fixed-Sequence, Pharmacokinetic Single Acending Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) Long-Acting Injectable(LAI) and IVL4002 in Healthy Subjects
- Conditions
- Opioid Dependence, Alcohol Dependence, Multiple Sclerosis
- Being tested
- Vivitrol Injectable Product, IVL3004, IVL4002
- Medical subject headings
- Opioid-Related Disorders, Alcoholism, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivitrol Injectable ProductDrug
Naltrexone Long-Acting Injection
IVL3004Drug
Naltrexone Long-Acting Injection
IVL4002Drug
Naltrexone Long-Acting Injection
| Study group | Role | What they receive |
|---|---|---|
| Part A Group 1 (Vivitrol Injection) | Active comparator | Vivitrol, Single Dose, IM injection Receives: Drug: Vivitrol Injectable Product |
| Part A Group 2 (IVL3004 A mg) | Experimental | IM, Single Dose Receives: Drug: IVL3004 |
| Part A Group 3 IVL3004 B mg) | Experimental | IM, Single Dose Receives: Drug: IVL3004 |
| Part B Group 1 (IVL4002 Cmg) | Experimental | SC, Single Dose Receives: Drug: IVL4002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-240
Area under the concentration-time curve from time zero to 240hrs
Measured: Pre-dose, up to Day 57
Cmax
The maximal observed concentration
Measured: Pre-dose, up to Day 57
AUC240-672
Area under the concentration-time curve from time 240 to 672hrs
Measured: Pre-dose, up to Day 57
AUC0-672
Area under the concentration-time curve from time zero to 672hrs
Measured: Pre-dose, up to Day 57
AUC0-inf
Area under the concentration-time curve from time zero to infinity
Measured: Pre-dose, up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start11 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inventage Lab., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620940
- Sponsor's protocol ID
- IVL3004-001
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, EXPLORATORY, FIXED-SEQUENCE, PHARMACOKINETIC SINGLE ASCENDING DOSE STUDY OF IVL3004 VERSUS VIVITROL® (NALTREXONE) LONG-ACTING INJECTABLE (LAI) AND IVL4002 IN HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT05620940
- Acronym / sponsor ID
- IVL3004-001
- Conditions
- Opioid Dependence, Alcohol Dependence, Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inventage Lab., Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Detailed description
A Phase 1, Open-Label, Exploratory, Fixed-Sequence, Pharmacokinetic Single Acending Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) Long-Acting Injectable(LAI) and IVL4002 in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Group 1 (Vivitrol Injection) | Active comparator | Drug: Vivitrol Injectable ProductVivitrol, Single Dose, IM injection |
| Part A Group 2 (IVL3004 A mg) | Experimental | Drug: IVL3004IM, Single Dose |
| Part A Group 3 IVL3004 B mg) | Experimental | Drug: IVL3004IM, Single Dose |
| Part B Group 1 (IVL4002 Cmg) | Experimental | Drug: IVL4002SC, Single Dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 clinical site).
- BMI ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg.
- Healthy as defined by:
- 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:
- Subjects who have had a vasectomy must be willing to use a condom until study exit.
Key exclusion criteria (23 listed)
- 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 determined by the Investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivitrol Injectable ProductNaltrexone Long-Acting Injection | Drug | Part A Group 1 (Vivitrol Injection) |
| IVL3004Naltrexone Long-Acting Injection | Drug | Part A Group 2 (IVL3004 A mg), Part A Group 3 IVL3004 B mg) |
| IVL4002Naltrexone Long-Acting Injection | Drug | Part B Group 1 (IVL4002 Cmg) |
Primary outcome
AUC0-240
Time frame: Pre-dose, up to Day 57
Area under the concentration-time curve from time zero to 240hrs
Cmax
Time frame: Pre-dose, up to Day 57
The maximal observed concentration
AUC240-672
Time frame: Pre-dose, up to Day 57
Area under the concentration-time curve from time 240 to 672hrs
AUC0-672
Time frame: Pre-dose, up to Day 57
Area under the concentration-time curve from time zero to 672hrs
AUC0-inf
Time frame: Pre-dose, up to Day 57
Area under the concentration-time curve from time zero to infinity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vivitrol Injectable Product, IVL3004 and IVL4002 in people with Opioid Dependence and Alcohol Dependence, run by Inventage Lab., Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HyeRyeon Kim (82-31-608-0514 ext. 5134, hr.kim@inventagelab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-240 (time frame: Pre-dose, up to Day 57). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.