Clinical trial NCT05868967: A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Official title: A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Phase 1 Study, Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Haini Pharmaceutical Co., Ltd.
First posted: 2023-05-22
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center, single-dose, open-label design
Primary purpose: OTHER

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

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

Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects aged 18 to 45 years (including boundary values);
2. Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values);
3. Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form;
4. 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);
5. 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:

1. 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;
2. Subjects with clinically significant abnormalities or medical history of hepatic, renal, gastrointestinal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urological, or psychiatric disorders;
3. 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;
4. 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);
5. 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;
6. 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;
7. 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;
8. 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;
9. Subjects who have taken any investigational product or participated in any clinical trial of drugs within 3 months prior to screening;
10. 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;
11. Subjects who have used any medication that alters liver enzyme activity within 4 weeks prior to dosing (see Appendix 1 for details);
12. 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;
13. 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;
14. Subjects with a history of fear of needles and hemophobia, difficulty in blood collection or intolerance to venipuncture blood collection; radiopharmaceutical labeling studies;
15. 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;
16. Subjects with other factors that are not suitable for participation in this study as judged by the investigator.

Primary outcomes:
measure: Tmax
timeFrame: Up to 168hours(approx) from administration
measure: Cmax
timeFrame: Up to 168hours(approx) from administration
measure: AUC0-t
timeFrame: Up to 168hours(approx) from administration
measure: AUC0-∞
timeFrame: Up to 168hours(approx) from administration
measure: t1/2
timeFrame: Up to 168hours(approx) from administration
measure: MRT
timeFrame: Up to 168hours(approx) from administration
measure: CL/F
timeFrame: Up to 168hours(approx) from administration
measure: Vd/F
timeFrame: Up to 168hours(approx) from administration
measure: Ratio of total radioactivity in whole blood/plasma
timeFrame: Up to 168hours(approx) from administration
measure: Cumulative recovery of total radioactive substances
timeFrame: Up to 168hours(approx) from administration
Secondary outcomes:
measure: To observe the safety of [14C]DWP14012
timeFrame: Up to study completion, approximately up to 2000 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Boren Hospital
Study officials:
affiliation: Beijing GoBroad Boren Hospital
name: Fang Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing GoBroad Boren Hospital
name: Wel Tan
role: PRINCIPAL_INVESTIGATOR
References: