A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SKL15508
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
- Must be male or non-pregnant, non-lactating female subjects, 18 to 60 years of age, inclusive
- Has a body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive
- 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
- Has been receiving a stable dose of antipsychotic medication for at least 1 month before Screening
- Has not had an acute exacerbation of psychosis or hospitalization for the treatment of schizophrenia for at least 3 months before Screening
- By history, has not had a marked change in smoking or tobacco/nicotine use from 30 days before Screening.
- Must reside in a stable residence for at least 8 weeks before the Screening Visit
Exclusion Criteria:
- 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
- Has a known sensitivity to sulfur-containing drugs or sulfates in food
- Taking any medication known to influence coagulation, such as acetylsalicylic acid (aspirin), and including prescription, herbal remedies, vitamin supplements and over-the-counter products
- 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
- 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
- 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
- Has an abnormal (clinically significant) electrocardiogram (ECG) at Screening or unit admission day
- Has a blood pressure and pulse rate outside the protocol defined ranges
- Has a QT interval or PR outside of the protocol defined ranges
- Has abnormal laboratory values that suggest a clinically significant underlying disease
- Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia
- 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
- Has been taking medication for a medical condition for less than 2 months even if at a stable dose or regimen
- Currently taking lithium or any psychotropic medication that cannot be discontinued for safety reasons
Sites / Locations
- Glendale Adventist Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SKL15508 High Dose
SKL15508 Medium Dose
SKL15508 Low Dose
Placebo
Arm Description
SKL15508 High Dose
SKL15508 Medium Dose
SKL15508 Low Dose
Placebo
Outcomes
Primary Outcome Measures
Number and percent of subjects experiencing an adverse event.
Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508.
Change from baseline in clinical laboratory assessments.
Change from baseline in vital signs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02205099
Brief Title
A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SKL15508 High Dose
Arm Type
Experimental
Arm Description
SKL15508 High Dose
Arm Title
SKL15508 Medium Dose
Arm Type
Experimental
Arm Description
SKL15508 Medium Dose
Arm Title
SKL15508 Low Dose
Arm Type
Experimental
Arm Description
SKL15508 Low Dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SKL15508
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number and percent of subjects experiencing an adverse event.
Time Frame
10 days
Title
Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508.
Time Frame
During the course of 10 days
Title
Change from baseline in clinical laboratory assessments.
Time Frame
10 days
Title
Change from baseline in vital signs.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Must be male or non-pregnant, non-lactating female subjects, 18 to 60 years of age, inclusive
Has a body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive
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
Has been receiving a stable dose of antipsychotic medication for at least 1 month before Screening
Has not had an acute exacerbation of psychosis or hospitalization for the treatment of schizophrenia for at least 3 months before Screening
By history, has not had a marked change in smoking or tobacco/nicotine use from 30 days before Screening.
Must reside in a stable residence for at least 8 weeks before the Screening Visit
Exclusion Criteria:
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
Has a known sensitivity to sulfur-containing drugs or sulfates in food
Taking any medication known to influence coagulation, such as acetylsalicylic acid (aspirin), and including prescription, herbal remedies, vitamin supplements and over-the-counter products
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
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
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
Has an abnormal (clinically significant) electrocardiogram (ECG) at Screening or unit admission day
Has a blood pressure and pulse rate outside the protocol defined ranges
Has a QT interval or PR outside of the protocol defined ranges
Has abnormal laboratory values that suggest a clinically significant underlying disease
Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia
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
Has been taking medication for a medical condition for less than 2 months even if at a stable dose or regimen
Currently taking lithium or any psychotropic medication that cannot be discontinued for safety reasons
Facility Information:
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia
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