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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NTX-253
DrugOral Capsule
Placebo
DrugOral capsule
Treatment groups
73 Participants
are divided into 5 treatment groupsGroup A: NTX-253 Part 1aExperimental treatment 1 intervention
Group B: Placebo Part 1aExperimental treatment 1 intervention
Group C: NTX-253 Part 1bExperimental treatment 1 intervention
Group D: NTX-253 Part 2Experimental treatment 1 intervention
Group E: Placebo Part 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of reported Adverse Events
Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events.
Time frame
From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).2
Number of Adverse Events of Special Interest (AESI)
Safety and tolerability will be assessed by the incidence and severity of AESIs.
Time frame
From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).3
Number of dose limiting treatment emergent adverse events (TEAE)
Safety and tolerability will be assessed by the incidence and severity of serious or dose limiting TEAEs.
Time frame
From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).4
Vital Signs: Change in blood pressure
Blood pressure measurements
Time frame
From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).Secondary outcomes
1
Maximum observed plasma concentration (Cmax) [Pharmacokinetics]
Samples will be collected periodically until: * 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose. * 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.
Time frame
From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.2
Time of Cmax (tmax) [Pharmacokinetics]
Samples will be collected periodically until: * 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose. * 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.
Time frame
From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.3
Apparent terminal half-life (t1/2)
Samples will be collected periodically until: * 72 hours after a single dose with optional samples collected at 96, 120, 144, and 168 post-dose. * 72 hours after multiple doses with optional samples collected at 96, 120, 144, and 168 hours after the last dose.
Time frame
From baseline until up to 168 hours after a single dose, or until up to 168 hours after the last dose in the multiple dose cohorts.4
Amount of unchanged drug excreted in urine (Ae) [urinary excretion)
Samples will be collected in select cohorts from baseline until 72 hours after a single dose, or at baseline and on the last dosing day after multiple dose administrations.
Time frame
From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort.Sponsors and contacts
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Source ClinicalTrials.gov