A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects

Detailed Description
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This study is a single-center, single-dose, non-randomized, open-label design with two parts. Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under the fasting conditions

Official Title
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A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects

Conditions
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Phase 1 Study, Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]DWP14012


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects aged 18 to 45 years (including boundary values); Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values); Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form; Have no plan for fertility/sperm donation during the study and within 1 year after completion of the study, and take strict contraceptive measures with their spouses (see Appendix 3 for details); Have good hygiene habits, and are able to communicate well with the investigator and complete the study in accordance with the study regulations. Exclusion Criteria: Subjects with an allergic constitution, including those with a history of drug allergy or allergic reactions and are known to be allergic to this product or other P-CABs, PPIs or other drugs (e.g., aspirin and antibiotics); and those who are allergic to any food ingredients or have special requirements for diet and unable to take the unified diet; Subjects with clinically significant abnormalities or medical history of hepatic, renal, gastrointestinal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urological, or psychiatric disorders; Subjects with abnormal and clinically significant results of vital signs, physical examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation function, thyroid functions (FT3, FT4, TSH), stool routine + occult blood), 12-lead electrocardiogram, abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) as judged by the investigator; Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening); Subjects with any medical condition that, in the opinion of the investigator, may increase the risk during the subject's participation in this study (especially a history of esophageal or gastrointestinal ulcers), may interfere with drug absorption, distribution, metabolism or excretion, or may impair protocol compliance; Subjects with frequent alcohol consumption within 6 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits containing 40% alcohol or 100 mL of wine); or alcoholics; or those with a positive alcohol breath test at screening and baseline admission; Subjects who have smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening and are unable to withdraw during the study; Subjects who have used soft drugs (e.g., cannabis) within 3 months before screening or hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year before screening; or have a history of drug abuse; or have a positive urine drug test at screening and baseline admission; Subjects who have taken any investigational product or participated in any clinical trial of drugs within 3 months prior to screening; Subjects who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have participated in blood donation within one month prior to screening with a total blood donation of ≥ 200 mL or total blood loss of ≥ 200 mL; or who have received blood transfusion; or who plan to donate blood within 1 month after the end of this study; Subjects who have used any medication that alters liver enzyme activity within 4 weeks prior to dosing (see Appendix 1 for details); Subjects who have used any prescription or over-the-counter drugs, any vitamin products, health care drugs or Chinese herbal medicines within 14 days prior to dosing; Subjects who have habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeine-containing beverages, and are unable to withdraw during the study; Subjects with a history of fear of needles and hemophobia, difficulty in blood collection or intolerance to venipuncture blood collection; radiopharmaceutical labeling studies; Subjects whose work requires long-term exposure to radioactive conditions; or who have significant radioactive exposure (≥ 2 chest/ abdominal CTs, or ≥ 3 other types of X-rays) within 1 year prior to screening; or who have participated in radiopharmaceutical labeling studies; Subjects with other factors that are not suitable for participation in this study as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A single-center, single-dose, open-label design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]DWP14012<br>Type: [14C]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension | Drug: [14C]DWP14012<br>* Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under fasting conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time to peak Concentration | Up to 168hours(approx) from administration | 
| Cmax | Maximum Concentration | Up to 168hours(approx) from administration | 
| AUC0-t | Area under the plasma concentraion-time curve | Up to 168hours(approx) from administration | 
| AUC0-∞ | Area under the curve from time 0 extrapolated to infinite time | Up to 168hours(approx) from administration | 
| t1/2 | Elimination Phase Half-life | Up to 168hours(approx) from administration | 
| MRT | Mean Residence Time | Up to 168hours(approx) from administration | 
| CL/F | apparent oral clearnace | Up to 168hours(approx) from administration | 
| Vd/F | apparent oral volume of distribution | Up to 168hours(approx) from administration | 
| Ratio of total radioactivity in whole blood/plasma | Total measured radioactivity content of urine and fecal samples collected at each sampling interval | Up to 168hours(approx) from administration | 
| Cumulative recovery of total radioactive substances | Measurement of cumulative recovery ratio in urine or/and feces to meet the criteria for termination | Up to 168hours(approx) from administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe the safety of [14C]DWP14012 | Adverse events, serious adverse events etc. | Up to study completion, approximately up to 2000 hours |