Schizophrenia
Conditions
Brief summary
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
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.
Interventions
DRUGAPN1125
APN1125 orally at ascending doses
DRUGPlacebo
Matching Placebo
Sponsors
Alpharmagen, Inc.
CoMentis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 urine following single oral doses: renal clearance calculated as APN1125 (CLR) | 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 plasma following single oral doses: apparent elimination half-life (t1/2) | 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 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 |
Countries
United States
Outcome results
None listed