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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05345509




Registration number
NCT05345509
Ethics application status
Date submitted
19/04/2022
Date registered
26/04/2022
Date last updated
22/08/2023

Titles & IDs
Public title
A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.
Scientific 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
Secondary ID [1] 0 0
IVL3003-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aricept Tablet
Treatment: Drugs - IVL3003

Active comparator: Aricept Tablet - Aricept Tablet, QD, PO

Experimental: IVL3003 (A mg) - SC, Single Dose

Experimental: IVL3003 (B mg) - SC, Single Dose

Experimental: IVL3003 (C mg) - SC, Single Dose


Treatment: Drugs: Aricept Tablet
Donepezil Tablet once daily P.O

Treatment: Drugs: IVL3003
Donepezil Long-Acting Injection, once S.C Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUClast of IVL3003
Timepoint [1] 0 0
Pre-dose, up to 1month
Primary outcome [2] 0 0
AUCinf of IVL3003
Timepoint [2] 0 0
Pre-dose, up to 1month
Primary outcome [3] 0 0
AUClast of Aricept
Timepoint [3] 0 0
Pre-dose, up to 1month
Primary outcome [4] 0 0
AUCinf of Aricept
Timepoint [4] 0 0
Pre-dose, up to 1month

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
1/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003
Trial website
https://clinicaltrials.gov/study/NCT05345509
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
SungJin Eum
Address 0 0
Country 0 0
Phone 0 0
82-31-608-5135
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05345509