Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP), Rheumatoid Arthritis (RA)
Conditions
Brief summary
This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.
Interventions
DRUGSKI-O-703 API in Capsules
SKI-O-703 API in Capsules 100mg
DRUGSKI-O-703 Formulated Granules in Capsules
SKI-O-703 Formulated Granules in Capsules 200mg
Sponsors
Oscotec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Korean or Caucasian adults aged 19 years and older at screening. Caucasian: An individual whose parents and grandparents are of European, North American, or Middle Eastern origin; who was born in Europe, North America, or West Asia; and who has resided outside these regions for less than 10 years 2. Body mass index (weight \[kg\] / height2 \[m\]2) between 18 and 30 kg/m2, and body weight not less than 50 kg. 3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. 4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, blood coagulation test, urinalysis or urine drug test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents. 5. Must sign voluntarily an informed consent form indicating they understand the purpose of, procedures required for, and comply to the prohibitions and restrictions specified in the study and is willing to participate in the study.
Exclusion criteria
1. Any significant surgical/medical procedure or trauma within 4 weeks before the planned first dose of the study drug or history of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair) 2. Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\], cough or fever, or a history of recurrent or chronic infections). 3. Unable to swallow multiple capsules by mouth. 4. Received an experimental drug within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled. Prior experience of participating in another clinical trial within 6 months before the planned first dose of the study drug. 5. Individuals who have dietary habits that may influence the absorption, distribution, metabolism, or excretion of the investigational product or who consume foods known to affect drug metabolism. 6. Before the start of the study (first day of administration) those who have donated whole blood or blood components within 8 weeks or within 2 weeks, respectively, or received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent until the end of the trial. 7. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening. 8. Individual unable to abstain from alcohol-, caffeine-, or xanthine-containing products within 72 hours before the first dose of study drug and during the study or who tested positive for drug abuse, alcohol at screening or check-in (Day -1). 10\) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception\* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug. \*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide. 14\) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure AUCt of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year |
| To measure Cmax of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To measure Tmax of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year |
| To measure t1/2 of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year |
| To measure Tmax of M2 and M4 | Approximately 1 year |
| To measure t1/2 of M2 and M4 | Approximately 1 year |
Countries
South Korea
Outcome results
None listed