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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Phase 1 Study, Healthy Volunteers
• Intervention / Treatment: Drug: [14C]DWP14012

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 Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing GoBroad Boren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Collaborators: Shanghai Haini Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Fang Hou, Beijing GoBroad Boren Hospital; Principal Investigator: Wel Tan, Beijing GoBroad Boren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Fexuprazan
• Other Study ID Numbers: DW_DWP14012112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No