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NCT06107803 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
A Phase 1 study, sponsored by Minerva Neurosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT06107803 is a Phase 1 study that has completed, run by Minerva Neurosciences. The registered enrollment target is 17 participants.
The verdict
NCT06107803, a Phase 1 study, has completed, sponsored by Minerva Neurosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of the Co-Administration of Roluperidone and Olanzapine in Adult Subjects with Moderate to Severe Negative Symptoms of Schizophrenia. The main question this clinical trial aims to answer are the pharmacodynamic and pharmacokinetic effects and safety of the concomitant therapy of Roluperidone with an established and widely used antipsychotic, such as olanzapine in order to provide further guidance to clinical practitioners that may prescribe off-label use of these drugs concomitantly in clinical practice. Eligible Participants will undergo the following study phases in the clinic: * Screening Phase: Between 2 and up to 28 days during which study eligibility will be established and subjects receiving psychotropics will be washed out. Subjects will remain inpatient at the clinical site at least through the end of Treatment Phase 2. * Treatment Phase 1: After the Baseline Visit, Roluperidone 64 mg/day will be administered as a monotherapy for 7 days (Days 1-7). * Treatment Phase 2: Concomitant administration of Olanzapine 10 mg/day and Roluperidone 64 mg/day for 10 days, starting on Day 8 (Days 8-17). Subjects may be discharged from the clinic at least 48 hours after the last administration of the study drugs and after the collection of the last plasma sample; however, the inpatient period may be extended at the discretion of the investigator. End of Study (EOS): Will take place at least 14 days after the last dose of the study.
Interventions
- DRUG Roluperidone 64 mg
- DRUG Olanzapine 10 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2024-01-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06107803
The ClinicalTrials.gov registry entry for NCT06107803 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minerva Neurosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Roluperidone 64 mg is the first listed.
NCT06107803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06107803 about?
NCT06107803 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia". The goal of this clinical trial is to evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of the Co-Administration of Roluperidone and Olanzapine in Adult Subjects with Moderate to Severe Negative Symptoms of Schizophrenia. The main question this clinical trial aims to answer ...
What is the current status of trial NCT06107803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2023-10-13. Estimated completion is 2024-01-12.
What interventions are being tested in trial NCT06107803?
The interventions under investigation include: Roluperidone 64 mg (DRUG), Olanzapine 10 MG (DRUG).
Who is sponsoring clinical trial NCT06107803?
This trial is sponsored by Minerva Neurosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
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