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

Constipation Clinical Trial

Official title:

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381703
• Other study ID #: YH12852-103(I)
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2017
• Last updated: December 18, 2017
• Start date: March 16, 2017
• Est. completion date: March 29, 2017

Study information

• Verified date: May 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• YH12852
YH12852 administration
• 14C-labeled YH12852
14C-labeled YH12852 administration

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity	Total radioactivity recovered	0 - 288 hours (post-dose)
Primary	Cmax of YH12852	Peak concentration of YH12852	0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Primary	AUClast of YH12852	Area under the concentration-time curve from time 0 to the last measurable time of YH12852	0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Primary	Fpo of YH12852	Oral bioavailability of YH12852	0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Secondary	Aef of YH12852	Amount excreted in feces of YH12852	0 - 288 hours (post-dose)
Secondary	Aeu of YH12852	Amount excreted in urine of YH12852	0 - 288 hours (post-dose)