A Phase 1 interventional study of XEP527 and Placebo in Schizophrenia, sponsored by Novartis Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment
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.
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
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 36 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1: Dose Level 1 XEP527
Drug: XEP527
Cohort 2: Dose Level 2 XEP527
Drug: XEP527
Cohort 3: Dose Level 3 XEP527
Drug: XEP527
Placebo
Drug: Placebo
Placebo
Drug: Placebo
Placebo
Drug: Placebo
Participants will receive XEP527
Placebo
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.
Time frame: Up to approximately 56 days
Pharmacokinetic (PK) parameter: Cmax of XEP527
Cmax is the maximum (peak) observed plasma concentration of XEP527 after dose administration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 1
Pharmacokinetic (PK) parameter: AUCtau of XEP527
AUCtau is the area under the plasma concentration-time curve.
Time frame: 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.
Time frame: Day 14
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.
Of 108 industry-sponsored phase 1 interventional studies under Schizophrenia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 16 months is above that.
Counting every sponsor, half of 133 studies reached it within 12 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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