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

NCT ID: NCT02331433

Last Updated: 2016-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental: 1

Group Type EXPERIMENTAL

APN1125

Intervention Type DRUG

APN1125 orally at ascending doses

Placebo Comparator: 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Interventions

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APN1125

APN1125 orally at ascending doses

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alpharmagen, Inc.

INDUSTRY

Sponsor Role collaborator

CoMentis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Han, MD

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials Medical Group

Locations

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PAREXEL Early Phase

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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APN1125-001

Identifier Type: -

Identifier Source: org_study_id

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