A Phase I Study to Investigate the ADME of KD101

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: KD101

• Registration Number: NCT02819934
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2016-05-20
• Study First Submitted: 2016-05-30
• Primary Completion: 2016-06-06
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Study Completion: 2018-12-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm1	KD101	experimental group

Primary Outcome Measures

Name	Time	Method
Total radioactivity at feces,urine,blood to measure total recovery rate	13day	radioactivity in nCi