Clinical trial NCT02331433: Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
Official title: A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
Collaborators: name: Alpharmagen, Inc.
First posted: 2015-01-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events
timeFrame: 8 days
measure: Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)
timeFrame: 8 days
measure: Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs
timeFrame: 8 days
measure: Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams
timeFrame: 8 days
measure: Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)
timeFrame: 8 days
Secondary outcomes:
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)
timeFrame: 24 hours
measure: Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL Early Phase
state: California
Study officials:
affiliation: California Clinical Trials Medical Group
name: David Han, MD
role: PRINCIPAL_INVESTIGATOR
References: