Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
- Registration Number
- NCT02331433
- Lead Sponsor
- CoMentis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Comparator: 2 Placebo - Experimental: 1 APN1125 -
- Primary Outcome Measures
Name Time Method 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 ECGs 8 days Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis) 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 adverse events 8 days
- Secondary Outcome Measures
Name Time Method 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 plasma clearance (CL/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 plasma following single oral doses: maximum observed plasma concentration (Cmax) 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 urine following single oral doses: renal clearance calculated as APN1125 (CLR) 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 extrapolated to infinity (AUCinf) 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: apparent volume of distribution (Vz/F) 24 hours
Trial Locations
- Locations (1)
PAREXEL Early Phase
🇺🇸Glendale, California, United States