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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:July 2014
End Date:June 2015

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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

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.


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
We found this trial at
1
site
Glendale, California 91206
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Glendale, CA
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