Trial · NCT07908680
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
NCT07908680, Phase 1, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia. Trials, record NCT07908680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908680
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
- NCT number
- NCT07908680
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Schizophrenia
- Interventions
- XEP527, Placebo
- First posted
- 2026-11-02
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) and serious adverse events (SAEs) | 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. |
| Secondary | Pharmacokinetic (PK) parameter: Cmax of XEP527 | Day 1 and Day 14 | Cmax is the maximum (peak) observed plasma concentration of XEP527 after dose administration. |
| Secondary | Pharmacokinetic (PK) parameter: Tmax of XEP527 | Day 1 and Day 14 | Tmax is the time to reach maximum (peak) XEP527 concentration after single-dose administration. |
| Secondary | Pharmacokinetic (PK) parameter: AUClast of XEP527 | Day 1 and Day 14 | AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of XEP527. |
| Secondary | Pharmacokinetic (PK) parameter: AUCinf of XEP527 | Day 1 | The AUCinf is the area under the plasma concentration from time zero to infinity. |
| Secondary | Pharmacokinetic (PK) parameter: AUC0-12h of XEP527 | Day 1 | Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12h) of XEP527 |
| Secondary | Pharmacokinetic (PK) parameter: AUCtau of XEP527 | Day 14 | AUCtau is the area under the plasma concentration-time curve. |
| Secondary | Pharmacokinetic (PK) parameter: Racc of XEP527 | Day 14 | The accumulation ratio defines the increase in XEP527 concentration at steady-state compared to the initial dose. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908680
GET https://conductscience.org/api/trials/v1/NCT07908680/registered