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

NCT05868967 | Unknown Phase 1

• 1 other identifier: DW_DWP14012112
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Phase 1 Study, Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• To observe the safety of [14C]DWP14012

  Up to study completion, approximately up to 2000 hours

Study Arms (1)

[14C]DWP14012

EXPERIMENTAL

Type: \[14C\]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension

Drug: [14C]DWP14012

Interventions

[14C]DWP14012 DRUG

Each subject will receive a single oral dose of \[14C\]DWP14012 suspension (containing approximately 40 mg/80 μCi \[14C\]DWP14012) under fasting conditions.

[14C]DWP14012

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead
• Shanghai Haini Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing GoBroad Boren Hospital

Beijing, China

Location

Study Officials

• Fang Hou

  Beijing GoBroad Boren Hospital

  PRINCIPAL INVESTIGATOR

• Wel Tan

  Beijing GoBroad Boren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-center, single-dose, open-label design

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 22, 2023
• Study Start: February 27, 2023
• Primary Completion: May 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-04

Locations

CN (1)