SchizophreniaPhase 1NCT07908680
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
A Phase 1 study testing XEP527 in people with Schizophrenia, run by Novartis Pharmaceuticals.
Trial summary
This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- XEP527
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2026to 6 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study
- Participants 18 to 65 years of age, inclusive at screening
- Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization
- Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI), version 7.0.2. at screening
- Participant meets the following requirements per PANSS at screening and baseline: Total PANSS score ≤ 110, Score ≤ 4 (moderate) for item P1-P7, Score ≤ 4 (moderate) for G9
- Participant is treated with a single antipsychotic (typical and/or atypical) with a stable dose for at least 12 weeks prior to randomization. Participant must agree to maintain the treatment with standard of care antipsychotic for the duration of the study
- Participants who are treated with psychotropic medications other than antipsychotics need to be taking these medications as a stable dose for at least 12 weeks before randomization
Who cannot join
- Participant experienced worsening of schizophrenia within 3 months prior to randomization documented by symptom exacerbation and/or hospitalizations (hospitalization for social management and/or day hospital programs within this time are acceptable)
- Participant was treated with Clozapine, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the last 6 months prior to randomization
- Participant meets the DSM-5 criteria for another psychotic disorder
- Participant has a history of substance or alcohol use disorder, except nicotine or caffeine, within 1 year before screening, or current abuse as determined by urine drug screen or alcohol test
- Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: A Randomized, Participant and Investigator-blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.
Read the detailed description
This is a randomized, participant and investigator blinded, placebo-controlled, multicenter study in stable schizophrenic patients divided into three dosing cohorts. This study will include a screening period up to 28 days, an inpatient treatment period of 28 days of the study drug (XEP527 or placebo) and a follow-up period of 28 days
- Conditions
- Schizophrenia
- Being tested
- XEP527, Placebo
- Keywords
- XEP527, stable schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEP527Drug
Participants will receive XEP527
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose Level 1 XEP527 | Experimental | Cohort 1: Dose Level 1 XEP527 Receives: Drug: XEP527 |
| Cohort 2: Dose Level 2 XEP527 | Experimental | Cohort 2: Dose Level 2 XEP527 Receives: Drug: XEP527 |
| Cohort 3: Dose Level 3 XEP527 | Experimental | Cohort 3: Dose Level 3 XEP527 Receives: Drug: XEP527 |
| Cohort 1: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Cohort 2: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Cohort 3: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: Up to approximately 56 days
Secondary outcomes (7)
Pharmacokinetic (PK) parameter: Cmax of XEP527
Cmax is the maximum (peak) observed plasma concentration of XEP527 after dose administration.
Measured: Day 1 and Day 14
Pharmacokinetic (PK) parameter: Tmax of XEP527
Tmax is the time to reach maximum (peak) XEP527 concentration after single-dose administration.
Measured: Day 1 and Day 14
Pharmacokinetic (PK) parameter: AUClast of XEP527
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of XEP527.
Measured: Day 1 and Day 14
Pharmacokinetic (PK) parameter: AUCinf of XEP527
The AUCinf is the area under the plasma concentration from time zero to infinity.
Measured: Day 1
Pharmacokinetic (PK) parameter: AUC0-12h of XEP527
Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12h) of XEP527
Measured: Day 1
Pharmacokinetic (PK) parameter: AUCtau of XEP527
AUCtau is the area under the plasma concentration-time curve.
Measured: Day 14
Pharmacokinetic (PK) parameter: Racc of XEP527
The accumulation ratio defines the increase in XEP527 concentration at steady-state compared to the initial dose.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start4 Nov 2026 (estimated)
- Primary completion6 Mar 2028 (estimated)
- Study completion6 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908680
- Sponsor's protocol ID
- CXEP527A12105
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant and Investigator-blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
- ClinicalTrials.gov ID
- NCT07908680
- Acronym / sponsor ID
- CXEP527A12105
- Conditions
- Schizophrenia
- Keywords
- XEP527, stable schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 6 Mar 2028 (estimated)
- Study completion
- 6 Mar 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.
Detailed description
This is a randomized, participant and investigator blinded, placebo-controlled, multicenter study in stable schizophrenic patients divided into three dosing cohorts. This study will include a screening period up to 28 days, an inpatient treatment period of 28 days of the study drug (XEP527 or placebo) and a follow-up period of 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose Level 1 XEP527 | Experimental | Drug: XEP527Cohort 1: Dose Level 1 XEP527 |
| Cohort 2: Dose Level 2 XEP527 | Experimental | Drug: XEP527Cohort 2: Dose Level 2 XEP527 |
| Cohort 3: Dose Level 3 XEP527 | Experimental | Drug: XEP527Cohort 3: Dose Level 3 XEP527 |
| Cohort 1: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Cohort 2: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Cohort 3: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent must be obtained prior to participation in the study
- Participants 18 to 65 years of age, inclusive at screening
- Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization
- Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI), version 7.0.2. at screening
- Participant meets the following requirements per PANSS at screening and baseline: Total PANSS score ≤ 110, Score ≤ 4 (moderate) for item P1-P7, Score ≤ 4 (moderate) for G9
Key exclusion criteria (6 listed)
- Participant experienced worsening of schizophrenia within 3 months prior to randomization documented by symptom exacerbation and/or hospitalizations (hospitalization for social management and/or day hospital programs within this time are acceptable)
- Participant was treated with Clozapine, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the last 6 months prior to randomization
- Participant meets the DSM-5 criteria for another psychotic disorder
- Participant has a history of substance or alcohol use disorder, except nicotine or caffeine, within 1 year before screening, or current abuse as determined by urine drug screen or alcohol test
- Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XEP527Participants will receive XEP527 | Drug | Cohort 1: Dose Level 1 XEP527, Cohort 2: Dose Level 2 XEP527, Cohort 3: Dose Level 3 XEP527 |
| PlaceboPlacebo | Drug | Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to approximately 56 days
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
7 secondary outcomes
Pharmacokinetic (PK) parameter: Cmax of XEP527
Time frame: Day 1 and Day 14
Pharmacokinetic (PK) parameter: Tmax of XEP527
Time frame: Day 1 and Day 14
Pharmacokinetic (PK) parameter: AUClast of XEP527
Time frame: Day 1 and Day 14
Pharmacokinetic (PK) parameter: AUCinf of XEP527
Time frame: Day 1
Pharmacokinetic (PK) parameter: AUC0-12h of XEP527
Time frame: Day 1
Pharmacokinetic (PK) parameter: AUCtau of XEP527
Time frame: Day 14
Pharmacokinetic (PK) parameter: Racc of XEP527
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XEP527 in people with Schizophrenia, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to approximately 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.