A Phase I Study to Investigate the ADME of KD101

Seoul National University

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Drug: KD101

Study type

Interventional

Funder types

Other

Identifiers

NCT02819934

KD101_hAME

Details and patient eligibility

About

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

Full description

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

Enrollment

6 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.