Single and multiple oral doses of NTX-253 in healthy adults and adults with stable schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase, placebo-controlled SAD (single ascending dose) and MAD (multiple ascending dose) trial that enrolls healthy volunteers and a limited number of adults with stable schizophrenia. Part 1 includes single ascending doses with a food-effect cohort and a cerebrospinal fluid (CSF) cohort in healthy volunteers, and Part 2 gives escalating doses daily for 10 days including cohorts of stable schizophrenia participants. Participants will receive either oral NTX-253 or placebo and will be monitored for safety, tolerability, and pharmacokinetics. Some schizophrenia cohorts will have antipsychotic medication withdrawn for up to eight days prior to dosing to evaluate tolerability in that population.

Why it matters

Who can join: the full rules

Primary Inclusion Criteria:

* Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control
* Part 1 a/b, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg/m2
* Participants in the food effect cohort must be willing to eat a single high fat breakfast
* (Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only)
* Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg/m2
* Positive and Negative Syndrome Scale (PANSS) total score \<80 at screening

Primary Exclusion Criteria:

* (Part 1a/b, Part 2 Healthy): History of or current clinically significant medical or mental illness
* Cancer diagnosis/treatment in the past 7 years
* Acute or chronic gastrointestinal conditions that would interfere with drug tolerance or absorption
* Any clinically significant, abnormal 12 lead ECG
* Part 2: Any primary DSM-5TR disorder other than schizophrenia
* Participants with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history; history of clozapine use.

Where it's running

• Collaborative Neuroscience Research, LLC - CenExel
  Los Alamitos, California, United States Recruiting

Study contacts

• Study coordinator: Doug Feltner, Chief Medical Officer, MD
• Email: doug.feltner@neurosterix.com
• Phone: +41 22 884 15 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.