Clinical trial NCT03381703: Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Constipation
Keywords: Accelerated Mass Spectrometry
Microtracer
Microdose
hAME
Absolute bioavailability
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Total radioactivity
timeFrame: 0 - 288 hours (post-dose)
measure: Cmax of YH12852
timeFrame: 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)
measure: AUClast of YH12852
timeFrame: 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)
measure: Fpo of YH12852
timeFrame: 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:
measure: Aef of YH12852
timeFrame: 0 - 288 hours (post-dose)
measure: Aeu of YH12852
timeFrame: 0 - 288 hours (post-dose)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: Howard Lee, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: