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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

APN1125

Placebo

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

PAREXEL Early Phase

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: 1

Placebo Comparator: 2

Arm Description

Outcomes

Primary Outcome Measures

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

Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)

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

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

Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)

Secondary Outcome Measures

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

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

Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast)

Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT02331433

First Posted

December 26, 2014

Last Updated

April 7, 2016

Sponsor

CoMentis

Collaborators

Alpharmagen, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02331433

Brief Title

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

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CoMentis

Collaborators

Alpharmagen, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: 1

Arm Type

Experimental

Arm Title

Placebo Comparator: 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

APN1125

Intervention Description

APN1125 orally at ascending doses

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

8 days

Title

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

Title

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

Time Frame

8 days

Title

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

Time Frame

8 days

Title

Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)

Time Frame

8 days

Secondary Outcome Measure Information:

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Title

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

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Han, MD

Organizational Affiliation

California Clinical Trials Medical Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

PAREXEL Early Phase

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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