Obesity
Conditions
Brief summary
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
Detailed description
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
Interventions
DRUGKD101
after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radioactivity at feces,urine,blood to measure total recovery rate | 13day | radioactivity in nCi |
Outcome results
None listed