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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.
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. NTX-253 is an investigational drug being developed for the treatment of schizophrenia. The study will consist of a single ascending dose (SAD - Part 1a) phase which will include a food effect cohort, and a cerebrospinal fluid (CSF - Part 1b) cohort in healthy volunteers. Participants will receive a single dose of either oral NTX-253 or placebo. The multiple ascending dose (MAD - Part 2) phase will follow. In Part 2, participants will be dosed for 10 consecutive days with either NTX-253 or placebo. Each phase will include sequential escalating doses in healthy volunteers. Two cohorts in the MAD phase will include stable schizophrenic adult participants who have had antipsychotic medication withdrawn for up to 8 days prior to dosing with NTX-253.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTX-253 Part 1a | Experimental | Participants will be assigned to receive one of multiple single ascending daily oral doses of NTX-253 |
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| Placebo Part 1a | Experimental | Participants will be assigned to receive one of multiple single ascending daily oral doses of placebo |
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| NTX-253 Part 1b | Experimental | Participants will receive the maximum tolerated single oral dose of NTX-253 |
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| NTX-253 Part 2 | Experimental | Participants will be assigned to receive one of multiple ascending oral daily doses of NTX-253 for 10 days |
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| Placebo Part 2 | Experimental | Participants will be assigned to receive one of multiple ascending daily oral doses of placebo for 10 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX-253 | Drug | Oral Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reported Adverse Events | Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events. | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Number of Adverse Events of Special Interest (AESI) | Safety and tolerability will be assessed by the incidence and severity of AESIs. | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| 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. | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Vital Signs: Change in blood pressure | Blood pressure measurements | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Vital Signs: Change in temperature | Oral temperature measurement | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Vital Signs: Change in respiratory rate | Respiratory rate (number of breaths per minute) measurements | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) [Pharmacokinetics] | Samples will be collected periodically until:
| 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. |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doug Feltner, Chief Medical Officer, MD | Contact | +41 22 884 15 55 | doug.feltner@neurosterix.com | |
| Lisa Corey | Contact | +41 22 884 15 55 | lisa.corey@neurosterix.com |
| Name | Affiliation | Role |
|---|---|---|
| Doug Feltner, MD | Neurosterix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research, LLC - CenExel | Recruiting | Los Alamitos | California | 90720 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Crossover design for fasted/fed cohort
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| Placebo |
| Drug |
Oral capsule |
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| Vital Signs: Change in heart rate | Pulse measurements. | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Change in physical examination | Investigator will perform complete physical exam and document any clinically significant conditions. | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Clinical Laboratory Tests | Hematology, serum chemistry, urinalysis, and coagulation tests. | From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia). |
| Time of Cmax (tmax) [Pharmacokinetics] | Samples will be collected periodically until:
| 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. |
| Apparent terminal half-life (t1/2) | Samples will be collected periodically until:
| 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. |
| 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. | From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort. |
| Percent of dose excreted as unchanged drug 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. | From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort. |
| Renal clearance (Clr) [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. | From baseline until 72 hours after a single dose, or until the last dosing on Day 10 in the multiple dose cohort. |
| Maximum observed CSF concentration (Cmax, CSF) [Pharmacokinetics] | CSF samples will be collected at periodic intervals until 12 hours after a single dose in a single dose CSF cohort. | From baseline until 12 hours after a single dose. |
| Time corresponding to Cmax (Tmax, CSF) [Pharmacokinetics] | CSF samples will be collected at periodic intervals until 12 hours after a single dose in a single dose CSF cohort. | From baseline until 12 hours after a single dose. |
| QT/QTc potential interval prolongation and plasma concentration | Electrocardiograms (ECGs) will be collected to assess the potential for QT/QTc interval prolongation and ΔQTc as measured by: • Change from baseline in cardiac measurements | From baseline until 72 hours post-dose in the single dose cohorts, then from baseline until Day 13 in the multiple dose cohorts. |