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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: APN1125

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Parexel Early Phase

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 1	Drug: APN1125; APN1125 orally at ascending doses
Placebo Comparator: Placebo Comparator: 2	Drug: Placebo; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CoMentis
• Collaborators: Alpharmagen, Inc.
• Investigators: Principal Investigator: David Han, MD, California Clinical Trials Medical Group

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 26, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: APN1125-001