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LY03010; paliperidone palmitate for Neurotransmitters

Phase 1
Waitlist Available
Research Sponsored by Luye Pharma Group Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 176 days
Awards & highlights

Study Summary

This study is evaluating whether a drug called LY03010 can improve sleep habits in people with dementia.

Eligible Conditions
  • Neurotransmitters
  • Psychotropic Medications
  • Tranquilizers
  • Mental Illness
  • Antipsychotics
  • Molecular Pharmacology
  • Central Nervous System Depressants
  • Drug Effects
  • Schizophrenia
  • Psychosis
  • Mood Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~176 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 176 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative Bioavailability of LY03010 compared to Listed Drug
The relative bioavailability of LY03010 versus INVEGA SUSTENNA at steady-state
Secondary outcome measures
Compare the PK profile between LY03010 and INVEGA SUSTENNA at the initial phase
Compare the PK profile between the two treatments at the initial phase.
Compare the PK profile between the two treatments.

Side effects data

From 2009 Phase 4 trial • 223 Patients • NCT01010776
15%
Insomnia
11%
Weight increased
11%
Anxiety
6%
Somnolence
6%
Headache
6%
Agitation
4%
Akathisia
4%
Psychomotor hyperactivity
4%
Depression
3%
Tremor
3%
Parkinsonism
3%
Psychotic disorder NOS
3%
Dizziness
2%
Hypertension NOS
2%
Weight decreased
2%
Schizophrenia NOS
2%
Dystonia
2%
Nausea
1%
Salivary hypersecretion
1%
Hallucination NOS
1%
Alopecia
1%
Logorrhea
1%
Depressed mood
1%
Extrapyramidal disorder
1%
Influenza like illness
1%
Muscle rigidity
1%
Speech disorder
1%
Confusional state
1%
Aggression
1%
Malaise
1%
Hospitalization
1%
Vomiting NOS
1%
Sedation
1%
Nervousness
1%
Libido decreased
1%
Psychomotor retardation
1%
Blood triglycerides increased
1%
Abdominal pain upper
1%
Dyslipidemia
1%
Diabetes mellitus NOS
1%
Appetite decreased NOS
1%
Appetite increased NOS
1%
Erectile dysfunction NOS
1%
Galactorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paliperidone ER - Main Phase
Paliperidone ER - Extension Phase

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LY03010 treatment groupExperimental Treatment1 Intervention
LY03010 (paliperidone palmitate) is a pharmaceutical equivalent drug product to the listed drug (LD) product INVEGA SUSTENNA. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3yl)piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4oxo-4Hpyrido[1,2-a]pyrimidin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89 g/mol. LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection. In LY03010 treatment group, all subjects will receive the first dose of 351 mg IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg IM injection in the gluteal muscle with the last dose on Day 141.
Group II: INVEGA SUSTENNA treatment groupActive Control1 Intervention
INVEGA SUSTENNA (234 mg, 156 mg) is manufactured by Janssen Pharmaceuticals, Inc and is commercially available. INVEGA SUSTENNA is provided in a prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). In SUSTENNA treatment group, all subjects will receive the first dose of 234 mg IM injection in the deltoid muscle on Day 1, and a second dose of 156 mg of IM injection in the deltoid muscle on Day 8, followed by five (5) monthly dosing of 156 mg IM injection in the gluteal muscle with the last dose on Day 148.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY03010; paliperidone palmitate
2021
Completed Phase 1
~290

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Luye Pharma Group Ltd.Lead Sponsor
58 Previous Clinical Trials
8,294 Total Patients Enrolled
Ying Dong, MD, PhDStudy ChairLuye Pharma US Ltd
Rui Li, MDStudy ChairLuye Pharma US Ltd
2 Previous Clinical Trials
4,589 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Relative Bioavailability of LY03010 Compared to Listed Drug
2021. "Relative Bioavailability of LY03010 Compared to Listed Drug". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922593.
~66 spots leftby Apr 2025
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