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

NCT02331433 | Completed Phase 1

• 1 other identifier: APN1125-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

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

  8 days

• 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

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

  8 days

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

  8 days

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

  8 days

Secondary Outcomes (12)

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

  24 hours

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

  24 hours

• 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

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

  24 hours

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

  24 hours

Study Arms (2)

Experimental: 1

EXPERIMENTAL

Drug: APN1125

Placebo Comparator: 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

APN1125 DRUG

APN1125 orally at ascending doses

Experimental: 1

Placebo DRUG

Matching Placebo

Placebo Comparator: 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CoMentis: lead
• Alpharmagen, Inc.: collaborator

Study Sites (1)

PAREXEL Early Phase

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David Han, MD

  California Clinical Trials Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: January 6, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2016-03

Locations

US (1)