A Phase I Study to Investigate the ADME of KD101

Study Overview
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Brief Summary
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A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

Detailed Description
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A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

Official Title
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A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: KD101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are able to provide written informed consent The subject is a healthy Korean aged 20 to 55 years, inclusive. The subject weighs at least 55 and has a body mass index (BMI)over 27 Exclusion Criteria: Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases. Subjects with evidence of gastrointestinal disease which can affect the absorption of drug. Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.) Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product Subject who have history of allergy. Subject who can not continue proper contraception method during study period. Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period Subjects who are unable to abstain from smoking during the PK/PD testing period Subjects who are unable to abstain from grapefruit or caffeine containing food 1 day prior the first administration of the investigational product Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br>experimental group | Drug: KD101<br>* after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity at feces,urine,blood to measure total recovery rate | radioactivity in nCi | 13day |