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
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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
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
No
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
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
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Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
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