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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05620940




Registration number
NCT05620940
Ethics application status
Date submitted
10/11/2022
Date registered
17/11/2022

Titles & IDs
Public title
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Scientific title
A Phase 1, Open-Label, Exploratory, Fixed-Sequence, Pharmacokinetic Single Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) Long-Acting Injectable (LAI) and IVL4002 in Healthy Subjects
Secondary ID [1] 0 0
IVL3004-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Dependence 0 0
Alcohol Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vivitrol Injectable Product
Treatment: Drugs - IVL3004
Treatment: Drugs - IVL4002

Active comparator: Part A Group 1 (Vivitrol Injection) - Vivitrol, Single Dose, IM injection

Experimental: Part A Group 2 (IVL3004 A mg) - IM, Single Dose

Experimental: Part A Group 3 IVL3004 B mg) - IM, Single Dose

Experimental: Part B Group 1 (IVL4002 Cmg) - SC, Single Dose


Treatment: Drugs: Vivitrol Injectable Product
Naltrexone Long-Acting Injection

Treatment: Drugs: IVL3004
Naltrexone Long-Acting Injection

Treatment: Drugs: IVL4002
Naltrexone Long-Acting Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC0-240
Timepoint [1] 0 0
Pre-dose, up to Day 57
Primary outcome [2] 0 0
Cmax
Timepoint [2] 0 0
Pre-dose, up to Day 57
Primary outcome [3] 0 0
AUC240-672
Timepoint [3] 0 0
Pre-dose, up to Day 57
Primary outcome [4] 0 0
AUC0-672
Timepoint [4] 0 0
Pre-dose, up to Day 57
Primary outcome [5] 0 0
AUC0-inf
Timepoint [5] 0 0
Pre-dose, up to Day 57

Eligibility
Key inclusion criteria
1. 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).
2. BMI =18.0 and =32.0 kg/m2 and body weight =55.0 kg.
3. Healthy as defined by:

1. 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.
2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological (including autoimmune), psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
4. 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 dosing.
5. Subjects who have had a vasectomy must be willing to use a condom until study exit.
6. Subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
7. Subjects must be willing not to donate sperm for 90 days after dosing.
8. Willing to undergo SC abdominal injection or IM ventral gluteal injection to allow for investigational drug administration.
9. 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination at screening or Day -1.
2. 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.
3. 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.
4. Any history of malignancy or neoplastic disease.
5. History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug, or to any excipient present in the formulations.
6. ALT, AST, or total bilirubin >1.5x upper limit of normal (ULN) at screening or Day -1.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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:

1. Depot injection or implant within 3 months prior to dosing;
2. Strong CYP inhibitors or inducers within 30 days prior to dosing;
3. Prescription medications within 14 days prior to dosing;
4. Any vaccine, including COVID-19 vaccine, within 7 days prior to dosing;
5. 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);
6. 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;
7. Anesthetic agents within 24 hours prior to dosing.
8. Anticoagulant medications from 15 days prior to dosing to 6 weeks post- dose.
13. 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.
14. 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.
15. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inventage Lab., Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
HyeRyeon Kim
Address 0 0
Country 0 0
Phone 0 0
82-31-608-0514
Fax 0 0
Email 0 0
hr.kim@inventagelab.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05620940