Status:
COMPLETED
Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852
Lead Sponsor:
Seoul National University Hospital
Conditions:
Constipation
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects
Detailed Description
Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852. Part 2 : Investigate the absolute bioavailability of YH1...
Eligibility Criteria
Inclusion
- Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
- Healthy adult, 19 - 55 of age (inclusive)
- Subjects weighing over 55 kg (inclusive) with BMI between 18 and 25 (inclusive) at screening visit
- Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results
Exclusion
- History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- History of (or suspected at screening visit) disease listed below Myocardial infarction Cerebral infarction/Stroke Arrythmia that need medical treatment Unstable angina Pulmonary hypertension
- Subjects who are positive for Hepatitis B, Hepatitis C, and HIV
- History of relevant allergy/hypersensitivity
- Subjects who took prescribed medications within 14 days or over-the-counter (OTC) medications within 7 days prior to the first dose of the study drug
- Subjects who have been consuming over 21 unit(1 unit = 10 g of alcohol) per week of alcohol prior to the study initiation or who is not able to stop consuming alcohol throughout the hospitalization period
- Subjects who consumed products listed below within 2 days prior to the first dose of the study drug or who is not able to stop consuming products listed below until the last site visit Foods and/or beverages containing grapefruit Products containing caffeine (Coffee, tea, chocolate, caffeine-containing soft drinks)
- Subject who is not willing to use contraception throughout the study
- Subjects who have smoked over 10 cigarettes until 3 months prior to the study initiation or who is not able to stop smoking throughout the hospitalization period
- Subjects who have donated whole blood within 2 months or blood component within 1 month or received blood transfusion within 1 month of participating in this study
- Administration of any investigational products within 3 months from the first dose of the study drug
- Subject who's serum prolactin is over 3-fold higher than the upper limit of normal range
- Subject who judged not eligible for study participation by investigator
Key Trial Info
Start Date :
March 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03381703
Start Date
March 16 2017
End Date
March 29 2017
Last Update
December 22 2017
Active Locations (1)
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1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea