A Phase 1, Randomized, Double-Blinded, Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study to Evaluate the Safety and Tolerability of SKL20540 in Healthy Subjects
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0002938
- Lead Sponsor
- SK Biopharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 92
1.19 to 55 years of age (inclusive) who volunteer for study participation and are able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening.
2.Subjects must agree to use 2 highly effective methods of contraception, including at least one barrier method.
3.55 kg = subjects weighing < 90 kg with body mass index (BMI) between 18.0 and 27.0 kg/m2 (inclusive) at screening.
4.Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology).
5.Not clinically significant ECG or normal ECG, arterial blood pressure (100 - 140/50 - 90 mmHg), and heart rate (50 90 bpm).
6.Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned.
7.Non-smokers (subjects who have stopped smoking at least 6 months before screening and showed a negative result in cotinine urine test at screening are eligible or who have not smoked)
1.History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
2.Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair).
3.Regular treatment with prescription medications. Subjects should have ended any prescription medications at least 14 days before the first dosing of the study drug. Potential subjects should only stop any prescribed medication at the direction of a physician.
4.Regular treatment with nonprescription medications. Subjects should have ended any nonprescription medications at least 14 days before the first dosing of the study drug. Potential subjects should consult a physician before stopping any regular treatment with nonprescription medication.
5.Consumption of herbal medications, dietary supplements, and specific fruit products. Subjects should have stopped consumption of herbal medications or dietary supplements (e.g., St. John’s Wort, ginkgo biloba, and garlic supplements), vitamins, and grapefruit or grapefruit juice, or Seville oranges at least 14 days before the first dosing of study drug.
6.History of drug or alcohol abuse or addiction within 2 years before the start of study drug dosing, or a positive test for alcohol or drugs of abuse, such as cotinine, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opioids at screening.
7.Regular consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint [473 mL] of beer or lager, 1 glass [125 mL] of wine, 25 mL shot of 40% spirit) before screening. Subjects may not consume any alcohol from 72 hours before the first dosing of study drug through the completion of the study (last visit).
8.Consumption of an average of more than 5 servings (8 ounces per serving) per day of coffee, cola, or other caffeinated beverage before screening. Subjects may not consume any caffeinated beverages from 48 hours prior to dosing until the collection of the last PK sample.
9.Participation in a clinical study involving administration of either an investigational or a marketed drug within 3 months before screening.
10.Blood donation or a significant loss of blood within 60 days of the start of study drug dosing or donation of more than 1 unit of plasma within 7 days before screening.
11.Positive result at screening for any of the following infectious disease tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antigen, antibody (HIV Ag, Ab).
12.Illness within 5 days before the start of study drug dosing (illness” is defined as an acute [serious or non-serious] condition [e.g., the flu or the common cold]).
13.Subjects with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption.
14.Agree not to donate sperm during the study and for at least 100 days after the last dose of the study medication.
15.History of relevant allergy/hypersensitivity (including allergy to aspirin, antibiotics, the trial medication or its excipients)
16.Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS (Columbia-Suicide Severity Rating Scale) or had a suicide attempt within 6 months prior to the screening vi
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method assessment of adverse events, clinically significant laboratory assessments, electrocardiograms (ECGs), C-SSRS (Columbia-Suicide Severity Rating Scale), RASS (Richmond Agitation-Sedation Scale), vital signs and peak expiratory flow rate (PEFR)
- Secondary Outcome Measures
Name Time Method terminal rate constant (?z);terminal half-life (t1/2?z);drug accumulation ratio;Electroencephalography (EEG);Mismatch Negativity (MMN);CANTAB task (Cambridge Neuropsychological Test Automated Battery);AUC over the dosing interval (AUC0-t);oral clearance (CL/F);apparent volume of distribution (Vz/F);time to reach Cmax (tmax);Maximum observed drug concentration (Cmax);lag-time (tlag);area under the plasma concentration versus time curve (AUC) from 0 to infinity (AUC0-inf);AUC from 0 to the last the last time point with a concentration above the lower limit of quantitation (AUC0-tlast)