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A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT02205099•SK Life Science, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Glendale Adventist Medical Center

Glendale, California, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

October 13, 2016

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

SKL15508

DRUG

Placebo

DRUG

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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