Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.

Detailed Description
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The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.

Official Title
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A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: APN1125
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females Aged 18 to 65 years, inclusive Body mass index (BMI) of 18 to 32kg/m^2 inclusive at Screening Non-smoker or no tobacco/nicotine usage with 30 days of Screening Exclusion Criteria: Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: 1<br> | Drug: APN1125<br>* APN1125 orally at ascending doses<br>|
| Placebo Comparator: Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events |  | 8 days | 
| Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature) |  | 8 days | 
| Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs |  | 8 days | 
| Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams |  | 8 days | 
| Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis) |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%) |  | 24 hours | 
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR) |  | 24 hours |