Skip to main content
OpenTrials
Completed

NCT Number: NCT03381703

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH12852

Drug

YH12852 administration

14C-labeled YH12852

Drug

14C-labeled YH12852 administration

Primary outcomes

  1. Total radioactivity

    Time frame: 0 - 288 hours (post-dose)

    Total radioactivity recovered

  2. Cmax of YH12852

    Time frame: 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)

    Peak concentration of YH12852

  3. AUClast of YH12852

    Time frame: 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)

    Area under the concentration-time curve from time 0 to the last measurable time of YH12852

  4. Fpo of YH12852

    Time frame: 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)

    Oral bioavailability of YH12852

Secondary outcomes

  1. Aef of YH12852

    Time frame: 0 - 288 hours (post-dose)

    Amount excreted in feces of YH12852

  2. Aeu of YH12852

    Time frame: 0 - 288 hours (post-dose)

    Amount excreted in urine of YH12852

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2017
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.