In Vivo Mass Balance Study of [14C]Hemay005

NCT05468645 | Completed Phase 1

• 1 other identifier: HM005MB1S01/CRC-C2209
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, single-dose, non-randomized, open-label study to evaluate the in vivo mass balance of \[14C\]Hemay005. Six healthy male subjects are planned to be enrolled.

Conditions

Health Volunteer

Outcome Measures

Primary Outcomes (7)

• pharmacokinetic (PK) profile of Hemay005

  peak concentration (Cmax)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

• pharmacokinetic (PK) profile of Hemay005

  time-to-peak (Tmax)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

• pharmacokinetic (PK) profile of Hemay005

  area under the curve (AUC0-t and AUC0-∞)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

• pharmacokinetic (PK) profile of Hemay005

  half-life (t1/2)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

• pharmacokinetic (PK) profile of Hemay005

  apparent clearance (CL/F)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

• pharmacokinetic (PK) profile of Hemay005

  apparent volume of distribution (Vd/F)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

• pharmacokinetic (PK) profile of Hemay005

  mean residence time (MRT0-t)

  The screening period/baseline period last about 14 day, and the observation period last about 11 day. The specimen collecting time and observation period may be adjusted appropriately according to the test results.

Study Arms (1)

[14C]Hemay005

EXPERIMENTAL

Drug: [14C]Hemay005

Interventions

[14C]Hemay005 DRUG

Name: \[14C\]Hemay005 Dose: 60 mg/100 µCi Storage: store at -10℃ to -30 °C, tightly closed and protected from light.

[14C]Hemay005

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fully understand the objectives and requirements of this study; willing to participate in the clinical study and sign the informed consent form; capable of communicating with investigators and completing the entire study as required;
• Healthy male subjects between the ages of 18-40 years (inclusive), with normal defecation (1-2 times a day);
• Body weight ≥ 50 kg, BMI: 19.0-26.0 kg/m2 (inclusive);
• Normal or abnormal but clinically insignificant results of vital signs, physical examination, laboratory tests (routine hematology, blood biochemistry, coagulation function, routine urinalysis, thyroid function, routine stool test + occult blood, etc.), 12-lead ECG, chest X-ray (posterior-anterior), and abdominal B-mode ultrasound (liver, gallbladder, pancreas, spleen, kidney, bladder);
• Male subjects of reproductive potential who promise to maintain no fathering or sperm donation plan, and voluntarily take effective contraceptive measures (such as complete abstinence, condom, contraceptive sponge, contraceptive gel, contraceptive film, intra-uterine contraceptive device, oral or injectable contraceptive, subcutaneous contraceptive implant, etc.) (contraceptive methods are detailed in Appendix 3) from admission to 6 months after the last dose.

You may not qualify if:

• Allergic constitution or allergic diseases, or known allergies to the ingredients, similar products or excipients of the investigational product;
• Hemorrhoids or perianal diseases with regular/ongoing hematochezia, habitual constipation or diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease and other diseases that affect the absorption, distribution, metabolism and excretion of oral drugs, or the safety evaluation of the investigational product; history of severe vomiting and diarrhea within 7 d before dosing;
• Previous history of peptic ulcer or bleeding, or any serious disease or condition that may affect the study results in the opinion of the investigators, including but not limited to disorders of the skin and mucous membrane, eyes, ears, noses, throat, circulatory system, endocrine system, respiratory system, nervous system, digestive system, urinary system, blood, immune, mentality, or metabolism, or chronic infectious diseases (such as tuberculosis).
• Positive for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus, or treponema pallidum antibody;
• Reception of major surgery within 6 months before dosing, or scheduled for a surgery during the study;
• History of drug abuse, or use of dope within 3 months before dosing, or positive for urine drug abuse screening;
• Mean smoking quantity \> 10 cigarettes/d 3 months before dosing;
• Regular drinkers within 3 months before dosing, that is, drinking volume \> 14 U of alcohol per week (1 U = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); positive breath alcohol test result;
• Blood loss or blood donation ≥ 400 mL within 3 months before dosing, or blood transfusion within 1 month before dosing;
• Use of any drug that inhibits or induces liver drug metabolism enzymes within 1 d before dosing (see Appendix 1 for details);
• Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements, such as vitamins and calcium supplements, within 14 d before dosing; participation in clinical trials of other drugs and reception of the investigational product within 3 months before dosing;
• Vaccination within 1 month before dosing or scheduled for a vaccination during the study;
• Special dietary requirements or unable to follow a uniform diet; history of needle or blood sickness, difficulty in blood collection, or intolerance of venipuncture blood collection;
• Long-term exposure to radioactivity, significant radioactive exposure (≥ 2 chest/abdomen CTs, or ≥ 3 other types of X-ray examinations); participation in radiolabeled drug trials within 1 year before dosing;
• ther factors that render the subjects unsuitable for participating in this study (determined by the investigators).

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• YanMei Liu

  Shanghai Xuhui District Central Hospital

  PRINCIPAL INVESTIGATOR

• GangYi Liu

  Shanghai Xuhui District Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The subjects fast for at least 10 h before dosing, take orally a suspension prepared with 60 mg of \[14C\]Hemay005 (approximately 100 µCi of radioactivity) and 240 mL of water, and then fast for another 4 h after dosing. One hour of water deprivation is required respectively before and after dosing (except water for dosing).

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 21, 2022
• Study Start: July 25, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)