Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNeurosterix
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
(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
Trial design
Treatments tested in this trial
- NTX-253
- Placebo
Treatment groups
73 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov