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Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects

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ClinicalTrials.gov Identifier: NCT01952132
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation

Brief Summary:
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: OMS643762 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: OMS643762 Low Dose
Orally administering OMS643762 low dose daily for 14 days
Drug: OMS643762
Other Name: OMS824

Experimental: OMS643762 High Dose
Orally administering OMS643762 high dose daily for 14 days
Drug: OMS643762
Other Name: OMS824

Placebo Comparator: Placebo
Orally administering placebo daily for 14 days
Drug: Placebo
Experimental: OMS643762 Medium Dose
Orally administering OMS643762 medium dose daily for 14 days
Drug: OMS643762
Other Name: OMS824




Primary Outcome Measures :
  1. Safety [ Time Frame: 14 days ]
    Incidence of adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Pre-dose and up to 10 days post-dose ]
    Maximum plasma concentration of OMS643762 following multiple-dose administration

  2. Pharmacokinetics [ Time Frame: Pre-dose and up to 10 days post-dose ]
    Area under the concentration-time curve of OMS643762 following multiple-dose administration

  3. Cognition [ Time Frame: Pre-dose and on day 14 of dosing ]
    Time to complete the Trail Making Test

  4. Cognition [ Time Frame: Pre-dose and on day 14 of dosing ]
    Number of correct responses on the Stroop Color and Word Test

  5. Cognition [ Time Frame: Pre-dose and on day 14 of dosing ]
    Number of correct responses on the Hopkin's Verbal Learning Test-Revised



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Competent to provide informed consent.
  • Voluntarily provide informed consent and Health Insurance Portability and Accounting Act (HIPAA) Authorization in accordance with local regulations and governing Institutional Review Board (IRB) requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
  • Have a diagnosis of schizophrenia as defined in DSM-IV-TR.
  • Are from 18 to 55 years of age inclusive at the screening visit.
  • Have stable schizophrenia symptomatology for greater than or equal to three months at the screening visit, in the opinion of the investigator.
  • For enrollment to Cohorts 1 and 2, have not taken any oral antipsychotic medication for at least seven days or any parenteral antipsychotic medication for at least 30 days prior to randomization. Subjects should have been on a stable medication regimen for greater than or equal to two months at the screening visit.
  • For enrollment to Cohorts 3, 4, and 5, have been on a stable medication regimen for greater than or equal to two months at the screening visit.
  • Have normal clinical laboratory test results and ECG, or results with minor deviations, which are not considered to be clinically significant by the investigator.
  • If able to reproduce, agree to use an acceptable method of birth control (e.g., condom and spermicide, oral birth control which has been stable for 30 days) or agree to remain abstinent from Visit 2 until 90 days after the last dose of study drug for males and 30 days after the last dose of study drug for females.

Exclusion Criteria:

  • Have a history of lactose intolerance or allergy to dairy products.
  • Are pregnant or lactating.
  • Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures.
  • Have a history of alcohol dependence (within 12 months of screening) or abuse (within six months of screening) as defined by DSM-IV-TR or consume excessive amounts of alcohol, in the opinion of the investigator.
  • Have a history of substance dependence (within 12 months of screening) or abuse (within six months of screening) as defined by DSM-IV-TR (with the exception of nicotine and caffeine). Positive results on drug screening will be exclusionary unless the patient has a valid prescription for the medication (i.e., benzodiazepines).
  • Have unstable depression, in the opinion of the investigator.
  • Have experienced EPS within 30 days prior to Visit 1.
  • Are currently taking clozapine.
  • Are currently taking aripiprazole (for enrollment to Cohorts 1 and 2).
  • Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Visit 1.
  • Have received treatment with an investigational drug or device within 60 days prior to Visit 1.
  • Have a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
  • Are an employee of Omeros, an investigator, a study staff member, or their immediate family member.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952132


Locations
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United States, California
Long Beach, California, United States, 90806
Sponsors and Collaborators
Omeros Corporation
Investigators
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Study Director: Albert Yu, MD Omeros Corporation

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Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT01952132     History of Changes
Other Study ID Numbers: OMS824-SCZ-001
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Keywords provided by Omeros Corporation:
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders