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Safety, Tolerability, and Pharmacokinetics of APN1125 in Subjects With Schizophrenia | Clinical Trials | Clareo Health

SUSPENDEDPHASE1/PHASE2

Safety, Tolerability, and Pharmacokinetics of APN1125 in Subjects With Schizophrenia

A Phase 1b/2a, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Subjects With Schizophrenia

NCT02724917•CoMentis

View on ClinicalTrials.gov

Summary

The purpose of this study in patients with schizophrenia is to evaluate the safety, tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with placebo when administered as repeated daily oral doses.

Detailed Description

The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics (PK) of APN1125 following 14 days of once-daily oral dosing in subjects with schizophrenia on stable second-generation antipsychotic therapy. This is a randomized, double-blind, 2-week, multiple ascending dose study of APN1125. This study will enroll up to three sequential cohorts of subjects diagnosed with schizophrenia, each randomly assigned to receive one of three doses (low, medium, or high) of APN1125 or matching placebo. Following admission to an Early Phase Clinical Unit (EPCU), APN1125 will be administered once daily for 2 weeks. All subjects will remain confined to the EPCU for a total of 20 days, consisting of admission, dosing and observation periods.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females of any race
•18 to 45 years of age, inclusive
•Diagnosed with schizophrenia, as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), in a non-acute (e.g., chronic) phase and clinically stable for at least 12 weeks before screening
•Currently on a stable second-generation anti-psychotic regimen (stable dose and medication for 12 weeks)
•Subjects (male and female) of childbearing potential must use two effective methods of contraception starting from the time of providing informed consent throughout the duration of the study and for 3 months after discharge
•Women of childbearing potential must have a negative pregnancy test at screening and at admission
•Subjects meeting DSM-5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine- or caffeine-related disorders) within 6 months prior to Screening
•Urine drug screen (UDS) positive for drugs of abuse (excluding prescribed benzodiazepines) or positive alcohol breath test at Screening and/or Baseline (may be repeated once if, in the judgment of the Investigator, the subject does not meet DSM-5 criteria for moderate to severe substance abuse disorder)
•Significant suicide risk as defined by 1) suicidal ideations as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the year prior to Screening or Baseline, 2) suicidal behaviors within the 2 years prior to Screening, or 3) Investigator assessment
•History of stroke, brain tumor, subdural hematoma, Parkinson's Disease, dementia or other clinically significant neurological condition
+9 more criteria

Exclusion Criteria

•Clinically significant abnormal serum electrolytes (sodium, potassium, calcium, and magnesium) after repeat testing
•Insulin-dependent diabetes or insufficiently controlled diabetes mellitus in the judgment of the Investigator
•Renal insufficiency with serum creatinine \>1.6 mg/dL Malignant tumor within the 5 years before Screening with the exception of treated squamous and basal cell carcinoma, cervical carcinoma in situ, or brachytherapy for localized prostate cancer
•Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
•Unstable medical condition that is clinically significant in the judgment of the Investigator
•Body mass index (BMI) \>38 kg/m\^2 at Screening ALT or AST \>1.5 times the upper limit of normal
•Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 and/or 2 antibodies
•Untreated clinically significant hypo- or hyperthyroidism; treated hypo- or hyperthyroidism should be stable for at least 8 weeks prior to Screening
•History of myocardial infarction or unstable angina within 6 months before Screening
•Cardiovascular disease history including symptomatic hypotension (supine systolic blood pressure \[SBP\] \<90 mmHg or supine diastolic blood pressure \[DBP\] \<60 mmHg), symptomatic orthostatic hypotension (orthostatic change in SBP \>20 mmHg or DBP \>15 mmHg), or hypertension (supine SBP \>160 mmHg or supine DBP \>95 mmHg ) or significant cardiac arrhythmia (in the judgment of the Investigator)
+2 more criteria

Locations (1)

Collaborative Neuroscience Network

Long Beach, California, United States

Key Dates

Start Date

April 1, 2016

Primary Completion Date

September 1, 2016

Completion Date

December 1, 2016

Last Updated

July 13, 2016

Enrollment

ESTIMATED participants

Conditions

Schizophrenia

Interventions

APN1125

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, and Pharmacokinetics of APN1125 in Subjects With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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