Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
Recruiting · NCT07344948 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurosterix
View the official record on ClinicalTrials.gov →Interventions studied
NTX-253Placebo
What this trial is about
This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Collaborative Neuroscience Research, LLC - CenExel - Los Alamitos, California, United States