Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852

Study Overview
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Brief Summary
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This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects

Detailed Description
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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 YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.

Official Title
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A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects

Conditions
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Constipation

Intervention / Treatment
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* Drug: YH12852
* Drug: 14C-labeled YH12852


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>Investigate the absorption, metabolism, and excretion of YH12852 | Drug: YH12852<br>* YH12852 administration<br>Drug: 14C-labeled YH12852<br>* 14C-labeled YH12852 administration<br>|
| Experimental: Part 2<br>Investigate the absolute bioavailability of YH12852 | Drug: YH12852<br>* YH12852 administration<br>Drug: 14C-labeled YH12852<br>* 14C-labeled YH12852 administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity | Total radioactivity recovered | 0 - 288 hours (post-dose) | 
| Cmax of YH12852 | Peak concentration of YH12852 | 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose) | 
| AUClast of YH12852 | Area under the concentration-time curve from time 0 to the last measurable time of YH12852 | 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose) | 
| Fpo of YH12852 | Oral bioavailability of YH12852 | 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aef of YH12852 | Amount excreted in feces of YH12852 | 0 - 288 hours (post-dose) | 
| Aeu of YH12852 | Amount excreted in urine of YH12852 | 0 - 288 hours (post-dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accelerated Mass Spectrometry, Microtracer, Microdose, hAME, Absolute bioavailability