Relative Bioavailability of LY03010 versus Paliperidone Palmitate (with Risperidone background) in Healthy Volunteers for Schizophrenia

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What is this study about?

Schizophrenia is a brain disorder that can affect thinking, feelings, and behavior. The study looks at two medicines that contain the active ingredient paliperidone and are given by intramuscular injection. One product is called Xeplion, and the other is a new version identified by the code name LY03010.

The purpose of the study is to compare how much of the drug becomes available in the body after a single dose of each product.

Healthy volunteers will receive one dose of each medicine and will be observed for a period of time. During this time, they will have blood samples taken to see how the drug is absorbed, and they will be checked for safety through simple exams, heart rhythm checks, and routine lab tests to record any side effects.

1 baseline assessments

after joining the study, you will complete a set of baseline assessments. these include a medical history review, a physical examination, and basic laboratory tests to confirm health status.

the purpose of these assessments is to document your condition before any study medication is given.

2 randomization

once baseline data are collected, you will be randomly assigned to receive either the test product ly03010 or the comparator product xeplion. randomization ensures that groups are comparable.

3 single intramuscular injection

you will receive one dose of paliperidone palmitate at a strength of 25 mg. the medication is administered as a intramuscular injection, which means it is injected into a muscle.

the injection is given only once during the entire study.

4 immediate observation

after the injection, you will remain in the clinic for a short observation period. staff will monitor you for any immediate reactions, such as changes in heart rhythm or blood pressure.

5 scheduled safety follow‑up visits

throughout the study period, you will attend scheduled visits for safety monitoring. at each visit, the following assessments will be performed:

ecg (a test that records the electrical activity of the heart),

vital signs (blood pressure, heart rate, temperature, and breathing rate),

a physical examination, and

laboratory tests (blood and urine analyses).

these visits help determine whether the study medication is well tolerated.

6 final study visit and completion

at the end of the study period, a final visit will be scheduled. during this visit, the same safety assessments as before will be performed, and any remaining study procedures will be completed.

after the final assessments, your participation in the study will be considered complete.

Who Can Join the Study?

You must be able and willing to sign a form that shows you understand the study, called informed consent.
You must be willing and able to follow all study procedures, follow any restrictions, and stay at the research center when the study requires an overnight stay.
You must be a man or woman who is at least 18 years old and not older than 55 years.
You must be considered healthy by the doctor after reviewing your medical history, lab tests, vital signs (such as blood pressure and heart rate), a full physical exam, and an ECG (a test that records the heart’s electrical activity).
Your body mass index (BMI), a measure of weight relative to height, must be between 18.5 and 30, and you must weigh at least 50 kg (about 110 lb) at screening.
A blood test for prolactin (a hormone) must be within the normal range.
If you are a woman, you must have a negative pregnancy test and meet one of these: be post‑menopausal for at least 12 months, have had surgery that makes pregnancy impossible (such as removal of the uterus or ovaries), or, if you could become pregnant, agree to use a highly effective birth‑control method (like an IUD, hormonal IUS, birth‑control pills, patches, implants, injectables, or have a partner with a successful vasectomy). These methods must be used for at least 21 days before the first dose and continue until the study ends.
If you are a man who could father children, you must agree to use a condom (or another acceptable birth‑control method) from the first dose until the study ends, if your partner could become pregnant.

Who Cannot Join the Study?

Having a serious past medical problem affecting the stomach, heart, brain, muscles, hormones, blood, kidneys, liver, lungs, nerves, immune system, or a known drug allergy that the doctor thinks would make it hard to take part.
Having a Hemoglobin A1c level of 5.7% or higher, which is a blood test that shows average blood sugar over the past few months.
Having reduced kidney function, shown by an estimated glomerular filtration rate (eGFR) less than 90 mL/min, which means the kidneys are not filtering blood well.
Testing positive for pregnancy or planning to become pregnant during the study (for women).
Being pregnant, breastfeeding, or being able to become pregnant without using reliable birth control.
Testing negative for COVID‑19 (SARS‑CoV‑2) or not having a valid EU Digital COVID‑19 Recovery Certificate.
Having had a severe case of COVID‑19 that required hospitalization, a machine called extracorporeal membrane oxygenation (ECMO), or a ventilator to help you breathe.
Receiving a COVID‑19 vaccine within 14 days before the first dose of the study drug, or planning to get vaccinated within 30 days after the dose.
Being in the hospital or having major surgery within 30 days before the screening visit.
Having an allergic reaction during a test that checks tolerance to the medication risperidone.
Having taken another experimental (investigational) medicine within 1 month, or within five half‑lives of that medicine, before screening.
Having a history of epilepsy or any seizure disorder, except for a single fever‑related seizure in childhood.
Donating or losing more than one unit of blood (about 450 mL) or experiencing acute blood loss within the 90 days before screening.
Having a white blood cell count lower than 3 × 10⁹/L, or having neutrophil levels (a type of white blood cell) outside the normal range.
Having a history of prescription‑drug or alcohol abuse, or using illegal drugs within the past 6 months or at the time of screening.
Testing positive for alcohol or illegal drugs during the screening tests.
Using any prescription medicines, over‑the‑counter drugs, or herbal supplements (including St John’s Wort) within 14 days before the study dose.
Drinking grapefruit or grapefruit juice within 7 days before the study dose.
Any medical finding or lab result that the doctor believes could be dangerous or could affect the study’s measurements.
Any recent illness, condition, or treatment that the doctor thinks would put you at undue risk or would change how the study drug works in your body.
Drinking any alcoholic beverage within the 24 hours before the screening visit.
Having a positive urine test for drugs of abuse or for ethanol (alcohol).
Having a history of Parkinson’s disease, Dementia with Lewy Bodies, or dementia‑related psychosis.
If you are a woman who could become pregnant, having a positive urine pregnancy test.
Any other condition that the doctor decides makes you unsuitable for the study.
Having a history of neuroleptic malignant syndrome (NMS) or tardive dyskinesia, which are serious reactions to certain medications that affect movement.
Being judged to have a significant risk of suicide based on a questionnaire or the doctor’s assessment.
Having had cancer (malignancy) within the past 5 years, except for fully cured basal cell or squamous cell skin cancer or early‑stage cervical cancer.
Having symptoms of orthostatic hypotension (a drop in blood pressure when standing) or a standing systolic blood pressure less than 105 mmHg, or a drop of 20 mmHg systolic or 10 mmHg diastolic when moving from lying down to standing.
Having a corrected QT interval (QTcF) longer than 450 milliseconds for men or 460 milliseconds for women on an ECG, or any other important heart‑electrical (ECG) abnormality.
Testing positive for HIV antibodies, hepatitis B surface antigen, or hepatitis C antibodies in the blood.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Balrkqrhzgid Ineunwyssxjj E Drtpfwchsaxyzei Em Stytz Ldkx	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	02.01.2023

Trial locations

Investigated Drugs:

Risperidone

Risperdal is an oral tablet that contains the antipsychotic medicine risperidone. In this study it is used as a background medication, meaning participants may be taking it as part of their usual treatment while the trial drugs are being tested. It is taken by mouth and works by helping to balance certain chemicals in the brain that affect mood and behavior.

Xeplion is a long‑acting injection that delivers the medicine paliperidone palmitate under the skin. In the trial it serves as the comparator, so it is the standard product that the new test drug is measured against. The injection slowly releases the medication over time, allowing for less frequent dosing compared with daily pills.

LY03010 is an investigational (experimental) long‑acting injectable form of paliperidone palmitate. It is the test product being studied to see how its absorption and overall availability in the body compare with the approved product Xeplion. Like Xeplion, it is given as a single intramuscular injection and is designed to release the medicine gradually.

Investigated Diseases:

Schizophrenia

Schizophrenia – Schizophrenia is a long‑lasting mental health condition that affects how a person thinks, feels, and behaves. It typically starts in late teens to early adulthood and may develop gradually or in distinct episodes. Common features include hearing voices or seeing things that are not present, strong false beliefs, confused speech, and reduced motivation or social interest. The disorder often follows a pattern of periods when symptoms become more intense and periods when they lessen. Over time, some people experience a relatively stable level of symptoms, while others have more noticeable changes in their condition. The course differs widely between individuals.

Trial ID:

2022-502179-48-00

Protocol code:

LY03010/CT-EUR-101

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Relative Bioavailability of LY03010 versus Paliperidone Palmitate (with Risperidone background) in Healthy Volunteers for Schizophrenia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?