RecruitingPhase 1NCT05620940

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.

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


Sponsor

Inventage Lab., Inc.

Enrollment

40 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how the body processes two investigational drugs — IVL3004 and IVL4002 — in healthy adult men, to understand their pharmacokinetics (how the drugs move through the body). **You may be eligible if...** - You are a healthy adult male between 18 and 55 years old - Your body mass index (BMI) is between 18 and 32, and you weigh at least 55 kg - You are a non-smoker or only occasional smoker (fewer than 10 cigarettes per week) - You have no significant history of medical or psychiatric illness - You are willing to use contraception and not donate sperm for 90 days after dosing **You may NOT be eligible if...** - You have any clinically significant illness, recent surgery, or infection in the past 4 weeks - You have a history of cardiovascular, neurological, kidney, liver, or immune system disease - You are unable to comply with contraception requirements - You are not male Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVivitrol Injectable Product

Naltrexone Long-Acting Injection

DRUGIVL3004

Naltrexone Long-Acting Injection

DRUGIVL4002

Naltrexone Long-Acting Injection


Locations(1)

Nucleus Network

Herston, Queensland, Australia

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NCT05620940


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