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SchizophreniaPhase 1/2NCT02724917

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

A Phase 1/2 study testing APN1125 in people with Schizophrenia, run by CoMentis at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Schizophrenia
What is being tested?
APN1125
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Apr 2016to Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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)
  • 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
  • Head trauma with loss of consciousness within 12 months prior to Screening
  • Active acute or chronic CNS infection
  • History of a seizure disorder
  • Immunosuppressants, including systemic corticosteroids (administered at an immunosuppressant dose in the judgment of the Investigator) (Note: Inhaled, nasal, or topical steroid use for allergy or other inflammation is permitted)
  • Any drugs with CNS activity (Note: Occasional (as needed) use of a sedative-hypnotic (e.g., benzodiazepine or nonbenzodiazepine [e.g., zolpidem, zaleplon, zopiclone, and eszopiclone]) as a sleep aid and stable second generation psychotics are permitted)
  • Prohibited antipsychotic medications (e.g., clozapine or typical, first-generation antipsychotics)
  • Excessive alcohol consumption (regular alcohol intake 14 units per week or more) or has a history of alcohol use disorder. Use of alcohol up to 48 hours before admission to the EPCU is not allowed.
  • Failure or inability to perform Screening or Baseline assessments
  • Exposure to an experimental drug or experimental medical device within 2 months before Screening, or an experimental biologic within 3 months before Screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Collaborative Neuroscience Network

    Long Beach, California, 90806

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Conditions
Schizophrenia
Being tested
APN1125, Placebo
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APN1125Drug

    Oral solid dose form of APN1125

  • PlaceboDrug

    Also called Placebo to match

    Placebo to match

Study groups in NCT02724917
Study groupRoleWhat they receive
APN1125, Low DoseExperimentalAPN1125, Low Dose
Receives: Drug: APN1125
APN1125, Mid DoseExperimentalAPN1125, Mid Dose
Receives: Drug: APN1125
APN1125, High DoseExperimentalAPN1125, High Dose
Receives: Drug: APN1125
PlaceboPlacebo comparatorPlacebo to match
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 25 days

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

    Measured: 25 days

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

    Measured: 25 days

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

    Measured: 25 days

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

    Measured: 25 days

Secondary outcomes (9)

  1. Maximum observed plasma APN1125 concentration (Cmax)

    Measured: Days 1 and 14

  2. Time corresponding to occurrence of Cmax (Tmax)

    Measured: Days 1 and 14

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

    Measured: Days 1 and 14

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

    Measured: Days 1 and 14

  5. Terminal plasma APN1125 rate constant (lambda z)

    Measured: Days 1 and 14

  6. Apparent plasma APN1125 terminal half-life (t1/2)

    Measured: Days 1 and 14

  7. Apparent APN1125 plasma clearance (CL/F)

    Measured: Days 1 and 14

  8. Amount of unmetabolized APN1125 excreted in urine (Ae)

    Measured: Days 1 and 14

  9. Fraction of unmetabolized APN1125 dose excreted in urine (Fe)

    Measured: Days 1 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionSep 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Why it stopped: Study halted by sponsor for business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02724917
Sponsor's protocol ID
APN1125-002
Status last verified
Jul 2016
First submitted
25 Mar 2016
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing APN1125 in people with Schizophrenia, run by CoMentis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via adverse events (time frame: 25 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02724917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.

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