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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02331433
• Other study ID #: APN1125-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 26, 2014
• Last updated: March 25, 2016
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: March 2016
• Source: CoMentis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• APN1125
APN1125 orally at ascending doses
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United States	PAREXEL Early Phase	Glendale	California

Sponsors (2)

Lead Sponsor	Collaborator
CoMentis	Alpharmagen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events		8 days	Yes
Primary	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	Yes
Primary	Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs		8 days	Yes
Primary	Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams		8 days	Yes
Primary	Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis)		8 days	Yes
Secondary	Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax)		24 hours	No
Secondary	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	No
Secondary	Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%)		24 hours	No
Secondary	Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR)		24 hours	No