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NCT04922593 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability of LY03010 Compared to Listed Drug
A Phase 1 study of Schizophrenia and Mood Disorders, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 281
- Enrollment target
- 9
- Study locations
NCT04922593: Completed Phase 1 study of Schizophrenia and Mood Disorders, sponsored by Luye Pharma Group.
NCT04922593 is a Phase 1 study of Schizophrenia and Mood Disorders that has completed, run by Luye Pharma Group. The registered enrollment target is 281 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (29% higher). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04922593, a Phase 1 study of Schizophrenia and Mood Disorders, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 281 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will stay at site till Day 2 after PK collection. All subjects will return to the clinical sites at designated study days for dosing, PK sample collections and assigned clinical activities. All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the gluteal muscle with the last dose on Day 148. End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last dosing. At EOS visit, subjects will complete the study after a series of assigned clinical assessments. A 30-day follow up call will be conducted by the clinical research staff to ensure participant's well-being.
Primary Outcome
The relative bioavailability of LY03010 versus INVEGA SUSTENNA will be evaluated by the analysis of the area under the plasma concentration-time curve over a dosing interval at steady state (AUCtau-ss) of plasma paliperidone.
Conditions Studied
Interventions
- DRUG LY03010; paliperidone palmitate
- DRUG INVEGA SUSTENNA
Study Locations (9)
California
- Collaborative Neuroscience Network, Inc. - Garden Grove
- Synergy San Diego - Lemon Grove
- CNS Network, LLC - Torrance
New Jersey
- Hassman Research Institute - Berlin
- Hassman Research Institute - Marlton
Texas
- InSite Clinical Research, LLC - DeSoto
- Pillar Clinical Research, LLC - Richardson
Florida
- Innovative Clinical Research, Inc. - Miami Lakes
Illinois
- Uptown Research Institute, LLC - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2022-04-15 |
| Phase | Phase 1 |
What the finished NCT04922593 record still lists
NCT04922593 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (29% higher).
The record links to 10 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which LY03010; paliperidone palmitate is the first listed.
NCT04922593 lists 9 locations in 5 states (California, New Jersey, Texas).
Frequently Asked Questions
What is clinical trial NCT04922593 about?
NCT04922593 is a clinical study titled "Relative Bioavailability of LY03010 Compared to Listed Drug". This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects ...
What is the current status of trial NCT04922593?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 281 participants. The study started on 2021-01-13. Estimated completion is 2022-04-15.
What conditions does trial NCT04922593 study?
This clinical trial studies the following conditions: Schizophrenia, Mood Disorders, Mental Disorders, Psychotic Disorders, Physiological Effects of Drugs.
What interventions are being tested in trial NCT04922593?
The interventions under investigation include: LY03010; paliperidone palmitate (DRUG), INVEGA SUSTENNA (DRUG).
Who is sponsoring clinical trial NCT04922593?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04922593 being conducted?
This trial has 9 study locations across California, Florida, Illinois, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04922593's enrollment target sits among peer trials
281 69th of 315 higher than 246 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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