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

NCT02724917 | Suspended Phase 1

• 1 other identifier: APN1125-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

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

  25 days

• Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature)

  25 days

• Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via ECGs

  25 days

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

  25 days

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

  25 days

Secondary Outcomes (9)

• Maximum observed plasma APN1125 concentration (Cmax)

  Days 1 and 14

• Time corresponding to occurrence of Cmax (Tmax)

  Days 1 and 14

• Area under the Curve from time zero to the last quantifiable plasma APN1125 concentration (AUClast)

  Days 1 and 14

• Area under the Curve from time zero extrapolated to plasma APN1125 concentration at infinity (AUCinf)

  Days 1 and 14

• Terminal plasma APN1125 rate constant (lambda z)

  Days 1 and 14

Study Arms (4)

APN1125, Low Dose

EXPERIMENTAL

APN1125, Low Dose

Drug: APN1125

APN1125, Mid Dose

EXPERIMENTAL

APN1125, Mid Dose

Drug: APN1125

APN1125, High Dose

EXPERIMENTAL

APN1125, High Dose

Drug: APN1125

Placebo

PLACEBO COMPARATOR

Placebo to match

Drug: Placebo

Interventions

APN1125 DRUG

Oral solid dose form of APN1125

APN1125, High Dose; APN1125, Low Dose; APN1125, Mid Dose

Placebo DRUG

Placebo to match

Also known as: Placebo to match

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females of any race
• 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

You may not qualify if:

• 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)
• Clinically significant abnormality on Screening or Baseline electrocardiogram (ECG), including but not necessarily limited to a confirmed QTcF (QT interval corrected for heart rate using Fridericia's formula) interval value \>450 msec for males or \>470 msec for females
• Current treatment with more than 2 atypical antipsychotics Psychiatric hospitalization due to breakthrough psychotic symptoms or acute exacerbations within 3 months before Day -1. Subjects with a recent "social" hospitalization may be screened after consultation with the Medical Monitor.
• Subjects with other DSM-5 disorders are ineligible if the comorbid condition is clinically unstable or has been the primary focus of treatment within 3 months prior to Screening
• 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)

Sponsors & Collaborators

• CoMentis: lead
• Alpharmagen, Inc.: collaborator

Study Sites (1)

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David P Walling, PhD

  Collaborative Neuroscience Network

  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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: March 31, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)