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

NCT03381703 | Completed Phase 1 DMC

• 1 other identifier: YH12852-103(I)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Total radioactivity

  Total radioactivity recovered

  0 - 288 hours (post-dose)

• 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)

• 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)

• 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 Outcomes (2)

• Aef of YH12852

  0 - 288 hours (post-dose)

• Aeu of YH12852

  0 - 288 hours (post-dose)

Study Arms (2)

Part 1

EXPERIMENTAL

Investigate the absorption, metabolism, and excretion of YH12852

Drug: YH12852; Drug: 14C-labeled YH12852

Part 2

EXPERIMENTAL

Investigate the absolute bioavailability of YH12852

Drug: YH12852; Drug: 14C-labeled YH12852

Interventions

YH12852 DRUG

YH12852 administration

Part 1; Part 2

14C-labeled YH12852 DRUG

14C-labeled YH12852 administration

Part 1; Part 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Constipation

Interventions

YH12852

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Howard Lee, MD., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: December 22, 2017
• Study Start: March 16, 2017
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: December 22, 2017

Record last verified: 2016-05

Locations

KR (1)