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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: Completed Phase 1 study, sponsored by Minerva Neurosciences.
NCT06107803 is a Phase 1 study that has completed, run by Minerva Neurosciences. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AIMS is a rating scale to measure tardive dyskinesia (TD). For the scoring, the AIMS scale has 14 items. The first 10 items (under categories of Facial and Oral Movements, Extremity Movements, Trunk Movements, and Global Judgements) are rated from 0 (none) to 4 (severe); the remaining 4 items (Dental Status) are rated "yes" and "no" and not counted. The analysis is limited to items 1 to 10, with each rated from 0 to 4. The total score is the sum of all 10 items and with values ranging from 0 to
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 |
What the finished NCT06107803 record still lists
NCT06107803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Roluperidone 64 mg is the first listed.
NCT06107803 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06107803's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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