A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorInventage Lab., Inc.
About this trial
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Vivitrol Injectable Product
DrugNaltrexone Long-Acting Injection
IVL3004
DrugNaltrexone Long-Acting Injection
IVL4002
DrugNaltrexone Long-Acting Injection
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Part A Group 1 (Vivitrol Injection)Active comparator 1 intervention
Group B: Part A Group 2 (IVL3004 A mg)Experimental treatment 1 intervention
Group C: Part A Group 3 IVL3004 B mg)Experimental treatment 1 intervention
Group D: Part B Group 1 (IVL4002 Cmg)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AUC0-240
Area under the concentration-time curve from time zero to 240hrs
Time frame
Pre-dose, up to Day 572
Cmax
The maximal observed concentration
Time frame
Pre-dose, up to Day 573
AUC240-672
Area under the concentration-time curve from time 240 to 672hrs
Time frame
Pre-dose, up to Day 574
AUC0-672
Area under the concentration-time curve from time zero to 672hrs
Time frame
Pre-dose, up to Day 57Sponsors and contacts
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Source ClinicalTrials.gov