A phase 1 clinical trial to investigate the absorption, metabolism and excretion of JBPOS0101 after oral administration of JBPOS0101 600 mg and 14C-labeled JBPOS0101 at a microdose in healthy adults
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0008718
- Lead Sponsor
- Bio-Pharm Solutions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6
1. Healthy male or female adults at the age of 19-50 years old at the time of informed consent
2. Body weight = 50.0 kg and body mass index (BMI) within the range of 19.0–30.0 kg/m2 at screening
? BMI = Body weight (kg)/(Height [m])2
3. Subjects who voluntarily decided to participate in the study after receiving and fully understanding detailed information on the study and provided written informed consent to comply with study instructions before the screening procedure
4. Subjects who are evaluated to be eligible by the investigator when assessed by physical examination, clinical laboratory tests, questionnaire, etc
1. Participants who had a clinically significant disease or history in hepatic, renal, neurological, immunologic, respiratory (sleep apnea syndrome, acute respiratory failure), metabolic disease or hemato-oncology, cardiovascular disease (heart failure, myocardial infarction), psychiatric disease (mood disorder, obsessive-compulsive disorder, etc.)
2. Participants who had any history or presence of a gastrointestinal disease (gastrointestinal ulcer, gastritis, gastric cramp, gastro-esophageal reflux disease, Crohn’s disease, etc.) which may affect the safety and PK/pharmacodynamics (PD) of the IP and any history of surgery in gastrointestinal system (except for simple appendectomy or herniotomy)
3. Participants who had any history of clinically significant hypersensitivity (including status asthmaticus, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.) to drugs associated with the IP or food assessed by the investigators
4. Subjects who have been exposed to radiation that exceeds the annual allowable effective dose limit (1 mSv (100 mrem)) for the general public within 1 year from the Screening or who may exceed the annual effective dose limit when administering this investigational product
5. Subjects who have worked in the field of radiation workers within 1 year prior to Screening, or who have experienced existing and planned exposure situations for the general public as defined by the ICRP as below.
[Existing exposure situation]
• Contamination of the area by residual radioactive materials originating from past nuclear facility operations, nuclear or radiation emergencies
• Residual contamination from activities previously subject to regulatory control that are not under current requirements
• Use of consumer goods such as food, drinking water, and building materials that contain natural or residual artificial radionuclides
• Exposure to indoor natural sources, including radon
[Planned exposure situation]
• Visiting controlled or supervised areas
• Access to accessible areas adjacent to controlled areas
• Managed release of radioactive materials into the environment
• Disposal of solid radioactive waste releases to the environment
• Use of radioactive goods
6. Any abnormalities at screening:
- AST (SGOT), ALT (SGPT) > 1.5 x upper limit of normal
- A positive result in serum tests (Syphilis tests, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) antigen-antibody test)
- If the estimated Glomerular Filtration Rate (eGRF) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula is < 60 mL/min/1.73m2
- Other clinically significant abnormalities
7. Participants who had a history of severe injury or planned to have a surgery within 12 weeks before screening
8. Participants who had a history of drug abuse or a positive result for drugs with abuse potential in the urine drug test
9. Participants who had a past or planned treatment with any prescription drugs or herbal medicine within 2 weeks, or any over the counter drugs, health functional foods, or vitamin supplements within 1 week prior to the first IP administration day (individual who was eligible based on other criteria may participate in the study at the discretion of the investigator)
10. Participants who had taken an inducer or inhibitor of any drug metabolic enzyme such as barbiturates, etc. within 1 month prior to the first IP administration day
11. Participants who ha
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method %Ae (total), %Ae,u (urine), %Ae,f (feces), %Ae,a (expired air) of 14C-labeled JBPOS0101
- Secondary Outcome Measures
Name Time Method 1) Cmax, AUClast, Tlag, Tmax, AUCinf, AUC%extrap, ?z, t1/2, CL/F, Vd/F, Ae (urine, feces, expired air, and total), CLR and MRT of total radioactivity of 14C-labeled JBPOS0101 2) Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F, Vd/F of JBPOS0101 ;Metabolites profiling and identification