A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Aricept Tablet
IVL3003
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female, ≥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 study site).
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg for males and ≥50.0 kg for females.
- Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit.
- Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
- Willing to abstain from use of non-steroidal anti-inflammatory drugs (NSAIDs) including ibuprofen, naproxen, aspirin, meloxicam, etc. from screening until study exit.
- 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.
Exclusion Criteria:
- Any clinically significant abnormal finding at physical examination at screening.
- Clinically significant abnormal laboratory test results or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.
- Positive pregnancy test at screening or Day -1 or lactating female subject.
- Positive drug or alcohol screen at screening or Day -1.
- Any history of malignancy or neoplastic disease.
- History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to donepezil, piperidine derivatives, dimenhydrinate or derivatives, benzatropine or derivatives, or other related drugs, or to any excipient present in the formulation for any study drug.
- Presence of hereditary disorders including galactose intolerance, lactase deficiency, and glucose-galactose malabsorption (for Part B only).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5x the upper limit of normal (ULN) at screening or Day -1.
- 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 <50 or >100 bpm) at screening or Day 1.
- History of significant bradycardia or atrioventricular (AV) block.
- History of significant asthma (except for fully resolved childhood asthma) or chronic obstructive pulmonary disease (COPD).
- 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%).
- History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 month, or use of codeine within 3 months prior to screening.
- 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.
- Consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day).
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Sites / Locations
- Nucleus NetworkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Aricept Tablet
IVL3003 (A mg)
IVL3003 (B mg)
IVL3003 (C mg)
Arm Description
Aricept Tablet, QD, PO
SC, Single Dose
SC, Single Dose
SC, Single Dose
Outcomes
Primary Outcome Measures
AUClast of IVL3003
Area under the concentration-time curve from time zero to last
AUCinf of IVL3003
Area under the concentration-time curve from time zero to infinity
AUClast of Aricept
Area under the concentration-time curve from time zero to last
AUCinf of Aricept
Area under the concentration-time curve from time zero to infinity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05345509
Brief Title
A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.
Official Title
A Phase 1, Randomized, Open-Label, Exploratory, Sequential, Pharmacokinetic Single Ascending Dose Study of IVL3003 Versus Multiple Doses of Aricept (Donepezil) Tablets in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inventage Lab., Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003
Detailed Description
A Phase 1, Randomized, Open-Label, Exploratory, Sequential, Pharmacokinetic Single Ascending Dose Study of IVL3003 Versus Multiple Doses of Aricept (Donepezil) Tablets in Healthy Subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aricept Tablet
Arm Type
Active Comparator
Arm Description
Aricept Tablet, QD, PO
Arm Title
IVL3003 (A mg)
Arm Type
Experimental
Arm Description
SC, Single Dose
Arm Title
IVL3003 (B mg)
Arm Type
Experimental
Arm Description
SC, Single Dose
Arm Title
IVL3003 (C mg)
Arm Type
Experimental
Arm Description
SC, Single Dose
Intervention Type
Drug
Intervention Name(s)
Aricept Tablet
Intervention Description
Donepezil Tablet once daily P.O
Intervention Type
Drug
Intervention Name(s)
IVL3003
Intervention Description
Donepezil Long-Acting Injection, once S.C Injection
Primary Outcome Measure Information:
Title
AUClast of IVL3003
Description
Area under the concentration-time curve from time zero to last
Time Frame
Pre-dose, up to 1month
Title
AUCinf of IVL3003
Description
Area under the concentration-time curve from time zero to infinity
Time Frame
Pre-dose, up to 1month
Title
AUClast of Aricept
Description
Area under the concentration-time curve from time zero to last
Time Frame
Pre-dose, up to 1month
Title
AUCinf of Aricept
Description
Area under the concentration-time curve from time zero to infinity
Time Frame
Pre-dose, up to 1month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female, ≥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 study site).
Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg for males and ≥50.0 kg for females.
Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit.
Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
Willing to abstain from use of non-steroidal anti-inflammatory drugs (NSAIDs) including ibuprofen, naproxen, aspirin, meloxicam, etc. from screening until study exit.
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.
Exclusion Criteria:
Any clinically significant abnormal finding at physical examination at screening.
Clinically significant abnormal laboratory test results or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.
Positive pregnancy test at screening or Day -1 or lactating female subject.
Positive drug or alcohol screen at screening or Day -1.
Any history of malignancy or neoplastic disease.
History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to donepezil, piperidine derivatives, dimenhydrinate or derivatives, benzatropine or derivatives, or other related drugs, or to any excipient present in the formulation for any study drug.
Presence of hereditary disorders including galactose intolerance, lactase deficiency, and glucose-galactose malabsorption (for Part B only).
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5x the upper limit of normal (ULN) at screening or Day -1.
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 <50 or >100 bpm) at screening or Day 1.
History of significant bradycardia or atrioventricular (AV) block.
History of significant asthma (except for fully resolved childhood asthma) or chronic obstructive pulmonary disease (COPD).
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%).
History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 month, or use of codeine within 3 months prior to screening.
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.
Consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day).
Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SungJin Eum
Phone
82-31-608-5135
Ext
5571
Email
sjeum@inventagelab.com
Facility Information:
Facility Name
Nucleus Network
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Hobbs
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.
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