NCT05620940

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Inventage Lab., Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Opioid Dependence
• Alcohol Dependence
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Vivitrol Injectable Product	Naltrexone Long-Acting Injection
DRUG	IVL3004	Naltrexone Long-Acting Injection
DRUG	IVL4002	Naltrexone Long-Acting Injection

Timeline

• Start date: 2024-09-11
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-11-17
• Last updated: 2025-09-15

Locations

1 site across 1 country: Australia