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

CoMentis58 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

APN1125DRUG

APN1125 orally at ascending doses

PlaceboDRUG

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PAREXEL Early Phase

Glendale, California, United States

Outcomes

Primary Outcomes

Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events

Time frame: 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)

Time frame: 8 days

Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs

Time frame: 8 days

Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams

Time frame: 8 days

Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)

Time frame: 8 days

Secondary Outcomes

Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)

Time frame: 24 hours

Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)

Time frame: 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)

Time frame: 24 hours

Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)

Time frame: 24 hours

Data from ClinicalTrials.gov

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