The purpose of this study in patients with schizophrenia is to evaluate the safety, tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with placebo when administered as repeated daily oral doses.
The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics (PK) of APN1125 following 14 days of once-daily oral dosing in subjects with schizophrenia on stable second-generation antipsychotic therapy. This is a randomized, double-blind, 2-week, multiple ascending dose study of APN1125. This study will enroll up to three sequential cohorts of subjects diagnosed with schizophrenia, each randomly assigned to receive one of three doses (low, medium, or high) of APN1125 or matching placebo. Following admission to an Early Phase Clinical Unit (EPCU), APN1125 will be administered once daily for 2 weeks. All subjects will remain confined to the EPCU for a total of 20 days, consisting of admission, dosing and observation periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Collaborative Neuroscience Network
Long Beach, California, United States
Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via adverse events
Time frame: 25 days
Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)
Time frame: 25 days
Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via ECGs
Time frame: 25 days
Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via physical exams
Time frame: 25 days
Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)
Time frame: 25 days
Maximum observed plasma APN1125 concentration (Cmax)
Time frame: Days 1 and 14
Time corresponding to occurrence of Cmax (Tmax)
Time frame: Days 1 and 14
Area under the Curve from time zero to the last quantifiable plasma APN1125 concentration (AUClast)
Time frame: Days 1 and 14
Area under the Curve from time zero extrapolated to plasma APN1125 concentration at infinity (AUCinf)
Time frame: Days 1 and 14
Terminal plasma APN1125 rate constant (lambda z)
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Time frame: Days 1 and 14
Apparent plasma APN1125 terminal half-life (t1/2)
Time frame: Days 1 and 14
Apparent APN1125 plasma clearance (CL/F)
Time frame: Days 1 and 14
Amount of unmetabolized APN1125 excreted in urine (Ae)
Time frame: Days 1 and 14
Fraction of unmetabolized APN1125 dose excreted in urine (Fe)
Time frame: Days 1 and 14