Skip to main content
OpenTrials
Completed

NCT Number: NCT02331433

Safety, Tolerability, and Pharmacokinetics of Single Doses 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL Early Phase

Glendale, California, 91206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APN1125

Drug

APN1125 orally at ascending doses

Placebo

Drug

Matching Placebo

Primary outcomes

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

    Time frame: 8 days

  2. 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

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

    Time frame: 8 days

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

    Time frame: 8 days

  5. 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

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

    Time frame: 24 hours

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

    Time frame: 24 hours

  3. 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

  4. 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

  5. Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)

    Time frame: 24 hours

  6. Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)

    Time frame: 24 hours

  7. Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)

    Time frame: 24 hours

  8. Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)

    Time frame: 24 hours

  9. Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)

    Time frame: 24 hours

  10. Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)

    Time frame: 24 hours

  11. Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)

    Time frame: 24 hours

  12. Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

CoMentis

Industry

Collaborators

  • Alpharmagen, Inc.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2015
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.