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A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.

PHASE1PHASE2RECRUITING

A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-04-01

Primary completion: 2024-03-31

Study completion finish: 2024-03-31

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05345509

Intervention or treatment

DRUG: Aricept Tablet

DRUG: IVL3003

Conditions

• Alzheimer Disease

Condition: Alzheimer Disease
DRUG: Aricept Tablet and other drugs
Melbourne, Not Specified, Australia
Sponsor: Inventage Lab., Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nucleus Network

Research sites nearby

Select from list below to view details:

Nucleus Network
Melbourne, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Aricept Tablet Aricept Tablet, QD, PO	DRUG: Aricept Tablet Donepezil Tablet once daily P.O
EXPERIMENTAL: IVL3003 (A mg) SC, Single Dose	DRUG: IVL3003 Donepezil Long-Acting Injection, once S.C Injection
EXPERIMENTAL: IVL3003 (B mg) SC, Single Dose	DRUG: IVL3003 Donepezil Long-Acting Injection, once S.C Injection
EXPERIMENTAL: IVL3003 (C mg) SC, Single Dose	DRUG: IVL3003 Donepezil Long-Acting Injection, once S.C Injection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
AUClast of IVL3003	Area under the concentration-time curve from time zero to last	Pre-dose, up to 1month
AUCinf of IVL3003	Area under the concentration-time curve from time zero to infinity	Pre-dose, up to 1month
AUClast of Aricept	Area under the concentration-time curve from time zero to last	Pre-dose, up to 1month
AUCinf of Aricept	Area under the concentration-time curve from time zero to infinity	Pre-dose, up to 1month

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.