A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [14C]DWP14012 Type: [14C]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension |
Drug: [14C]DWP14012
Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under fasting conditions.
|
Outcome Measures
Primary Outcome Measures
- Tmax [Up to 168hours(approx) from administration]
Time to peak Concentration
- Cmax [Up to 168hours(approx) from administration]
Maximum Concentration
- AUC0-t [Up to 168hours(approx) from administration]
Area under the plasma concentraion-time curve
- AUC0-∞ [Up to 168hours(approx) from administration]
Area under the curve from time 0 extrapolated to infinite time
- t1/2 [Up to 168hours(approx) from administration]
Elimination Phase Half-life
- MRT [Up to 168hours(approx) from administration]
Mean Residence Time
- CL/F [Up to 168hours(approx) from administration]
apparent oral clearnace
- Vd/F [Up to 168hours(approx) from administration]
apparent oral volume of distribution
- Ratio of total radioactivity in whole blood/plasma [Up to 168hours(approx) from administration]
Total measured radioactivity content of urine and fecal samples collected at each sampling interval
- Cumulative recovery of total radioactive substances [Up to 168hours(approx) from administration]
Measurement of cumulative recovery ratio in urine or/and feces to meet the criteria for termination
Secondary Outcome Measures
- To observe the safety of [14C]DWP14012 [Up to study completion, approximately up to 2000 hours]
Adverse events, serious adverse events etc.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male subjects aged 18 to 45 years (including boundary values);
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Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values);
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Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form;
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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);
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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:
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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;
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Subjects with clinically significant abnormalities or medical history of hepatic, renal, gastrointestinal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urological, or psychiatric disorders;
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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;
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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);
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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;
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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;
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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;
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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;
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Subjects who have taken any investigational product or participated in any clinical trial of drugs within 3 months prior to screening;
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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;
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Subjects who have used any medication that alters liver enzyme activity within 4 weeks prior to dosing (see Appendix 1 for details);
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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;
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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;
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Subjects with a history of fear of needles and hemophobia, difficulty in blood collection or intolerance to venipuncture blood collection; radiopharmaceutical labeling studies;
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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;
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Subjects with other factors that are not suitable for participation in this study as judged by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing GoBroad Boren Hospital | Beijing | China |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Shanghai Haini Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Fang Hou, Beijing GoBroad Boren Hospital
- Principal Investigator: Wel Tan, Beijing GoBroad Boren Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012112