A Phase I Study to Investigate the ADME of KD101

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: KD101

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2016
• Primary Completion (Actual): June 6, 2016
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: KD101_hAME