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Recruiting NCT07061288

A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT

Phase I Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KarXT.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Phase 1, Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long-Acting Injectable KarXT Formulation in Participants With Schizophrenia

Overview

A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia

Interventions

  • Drug KarXT
    Specified dose on specified days

Primary outcome measures

  • Number of participants with adverse events (AEs) [Time frame: Up to 3 weeks]
  • Number of participants with adverse events of special interest (AESIs) [Time frame: Up to 3 weeks]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to 3 weeks]
Secondary outcome measures (11)
  • Maximum concentration (Cmax) [Time frame: Up to 15 weeks]
  • Time to maximum concentration (Tmax) [Time frame: Up to 15 weeks]
  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Time frame: Up to 15 weeks]
  • Area under the plasma concentration-time curve from time zero to infinity (AUC(INF)) [Time frame: Up to 15 weeks]
  • Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672)) [Time frame: Up to 15 weeks]
  • Apparent terminal phase half-life (T-HALF) [Time frame: Up to 15 weeks]
  • Apparent total body clearance (CLT/F) [Time frame: Up to 15 weeks]
  • Apparent volume of distribution of terminal phase (Vz/F) [Time frame: Up to 15 weeks]
  • Number of participants with AEs [Time frame: Up to 3 weeks]
  • Number of participants with AESIs [Time frame: Up to 3 weeks]
  • Number of participants with SAEs [Time frame: Up to 3 weeks]

Eligibility criteria

Inclusion criteria

  • Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2).
  • Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline.
  • Participants must have a body mass index (BMI) between 18 and 40 kg/m².
  • Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements.

Exclusion criteria

  • Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia.
  • Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder.
  • Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results.
  • Participants must not be at risk for suicidal behavior.
  • Female participants must not be pregnant or breastfeeding.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Collaborative Neuroscience Research, LLC — Los Alamitos
  • Research Centers of America ( Hollywood ) — Hollywood
  • Innovative Clinical Research, Inc. — Miami Lakes
  • Atlanta Center for Medical Research — Atlanta
  • CenExel iResearch, LLC — Decatur
  • Uptown Research Institute — Chicago
  • Hassman Research Institute Marlton Site — Marlton
  • Community Clinical Research — Austin

Identifiers

NCT: NCT07061288 · CN012-0016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗