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A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02205099
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : October 13, 2016
Information provided by (Responsible Party):
SK Life Science, Inc.

Brief Summary:
This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SKL15508 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Double-blind, Flexible-dosage, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia
Study Start Date : July 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: SKL15508 High Dose
SKL15508 High Dose
Drug: SKL15508
Experimental: SKL15508 Medium Dose
SKL15508 Medium Dose
Drug: SKL15508
Experimental: SKL15508 Low Dose
SKL15508 Low Dose
Drug: SKL15508
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Number and percent of subjects experiencing an adverse event. [ Time Frame: 10 days ]
  2. Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508. [ Time Frame: During the course of 10 days ]
  3. Change from baseline in clinical laboratory assessments. [ Time Frame: 10 days ]
  4. Change from baseline in vital signs. [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The subject or, when applicable, the subject's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  2. Participants who are nonsterile and sexually active agree to use a double-barrier method of contraception (must be used regardless of any other contraception in use) from the time of providing informed consent throughout the duration of the study and for 12 weeks after the last dose of study drug. Nonsterile males must be advised not to donate sperm and women should not donate ova throughout the duration of the study and for 12 weeks after the last dose of study drug.
  3. Must be male or non-pregnant, non-lactating female subjects, 18 to 60 years of age, inclusive
  4. Has a body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive
  5. Has a clinical diagnosis of schizophrenia and, in the opinion of the Investigator, is able to safely be off his or her prescribed antipsychotic medications while participating in the study and has a very high likelihood of not deteriorating over a 3-week timeframe when off standard of care as outpatients during the Screening Period
  6. Has been receiving a stable dose of antipsychotic medication for at least 1 month before Screening
  7. Has not had an acute exacerbation of psychosis or hospitalization for the treatment of schizophrenia for at least 3 months before Screening
  8. By history, has not had a marked change in smoking or tobacco/nicotine use from 30 days before Screening.
  9. Must reside in a stable residence for at least 8 weeks before the Screening Visit

Exclusion Criteria:

  1. At risk of suicide (e.g., per Columbia Suicide Severity Rating Scale [C-SSRS]) or have made a suicide attempt in the 6 months before Screening
  2. Has a known sensitivity to sulfur-containing drugs or sulfates in food
  3. Taking any medication known to influence coagulation, such as acetylsalicylic acid (aspirin), and including prescription, herbal remedies, vitamin supplements and over-the-counter products
  4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the subject to participate or potentially confound the study results
  5. Has a positive urine drug result for drugs of abuse (i.e., illicit, illegal or without valid prescription or medical need) at Screening or Admission
  6. Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days before Day 1
  7. Has an abnormal (clinically significant) electrocardiogram (ECG) at Screening or unit admission day
  8. Has a blood pressure and pulse rate outside the protocol defined ranges
  9. Has a QT interval or PR outside of the protocol defined ranges
  10. Has abnormal laboratory values that suggest a clinically significant underlying disease
  11. Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia
  12. Has a medical condition other than schizophrenia (e.g., dementia, antisocial personality, borderline personality disorders) that can cause cognitive impairment or interfere with the performance or completion of study-defined procedures
  13. Has been taking medication for a medical condition for less than 2 months even if at a stable dose or regimen
  14. Currently taking lithium or any psychotropic medication that cannot be discontinued for safety reasons

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 identifier (NCT number): NCT02205099

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United States, California
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Sponsors and Collaborators
SK Life Science, Inc.

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Responsible Party: SK Life Science, Inc. Identifier: NCT02205099     History of Changes
Other Study ID Numbers: SKL15508C003
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: August 2015
Keywords provided by SK Life Science, Inc.:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders