Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852

NCT ID: NCT03381703

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-16
• Study Completion Date: 2017-03-29

Brief Summary

This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects

Detailed Description

Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.

Part 2

: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.

Conditions

Constipation

Keywords

Accelerated Mass Spectrometry; Microtracer; Microdose; hAME; Absolute bioavailability

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1

Investigate the absorption, metabolism, and excretion of YH12852

Group Type: EXPERIMENTAL

YH12852

Intervention Type: DRUG

YH12852 administration

14C-labeled YH12852

Intervention Type: DRUG

14C-labeled YH12852 administration

Part 2

Investigate the absolute bioavailability of YH12852

Group Type: EXPERIMENTAL

YH12852

Intervention Type: DRUG

YH12852 administration

14C-labeled YH12852

Intervention Type: DRUG

14C-labeled YH12852 administration

Interventions

YH12852

YH12852 administration

Intervention Type: DRUG

14C-labeled YH12852

14C-labeled YH12852 administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
• Healthy adult, 19 - 55 of age (inclusive)
• Subjects weighing over 55 kg (inclusive) with BMI between 18 and 25 (inclusive) at screening visit
• Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results

Exclusion Criteria

• History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
• History of (or suspected at screening visit) disease listed below Myocardial infarction Cerebral infarction/Stroke Arrythmia that need medical treatment Unstable angina Pulmonary hypertension
• Subjects who are positive for Hepatitis B, Hepatitis C, and HIV
• History of relevant allergy/hypersensitivity
• Subjects who took prescribed medications within 14 days or over-the-counter (OTC) medications within 7 days prior to the first dose of the study drug
• Subjects who have been consuming over 21 unit(1 unit = 10 g of alcohol) per week of alcohol prior to the study initiation or who is not able to stop consuming alcohol throughout the hospitalization period
• Subjects who consumed products listed below within 2 days prior to the first dose of the study drug or who is not able to stop consuming products listed below until the last site visit Foods and/or beverages containing grapefruit Products containing caffeine (Coffee, tea, chocolate, caffeine-containing soft drinks)
• Subject who is not willing to use contraception throughout the study
• Subjects who have smoked over 10 cigarettes until 3 months prior to the study initiation or who is not able to stop smoking throughout the hospitalization period
• Subjects who have donated whole blood within 2 months or blood component within 1 month or received blood transfusion within 1 month of participating in this study
• Administration of any investigational products within 3 months from the first dose of the study drug
• Subject who's serum prolactin is over 3-fold higher than the upper limit of normal range
• Subject who judged not eligible for study participation by investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Lee, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YH12852-103(I)

Identifier Type: -

Identifier Source: org_study_id