A Phase I Study to Investigate the ADME of KD101

NCT02819934 | Completed Phase 1

• 1 other identifier: KD101_hAME
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Total radioactivity at feces,urine,blood to measure total recovery rate

  radioactivity in nCi

  13day

Study Arms (1)

Arm1

EXPERIMENTAL

experimental group

Drug: KD101

Interventions

KD101 DRUG

after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral

Arm1

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 30, 2016
• Study Start: May 20, 2016
• Primary Completion: June 6, 2016
• Study Completion: December 15, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03