In Vivo Mass Balance Study of [14C]Hemay005

February 27, 2024 updated by: Ganzhou Hemay Pharmaceutical Co., Ltd

In Vivo Mass Balance Study of a Single Oral Dose of [14C]Hemay005 in Healthy Chinese Male Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The subjects are examined during the screening period (D-14 to D-2) and those who are qualified for the preliminary assessment are admitted to the clinical research center after qualification against the inclusion and exclusion criteria (D-2). After admission, they are trained on medication, urine and feces collection and other procedures to make sure that they can perform relevant operations according to the requirements of the protocol and corresponding operation manuals or procedures. Random urine and feces specimens (-24 h-0 h) are collected before dosing (D-1) and the subjects are deprived of food for at least 10 h and water for 1 h before dosing. On the morning of the first day of the study (D1), blood specimens are collected within 1 h before dosing, and the investigational product is taken orally on an empty stomach. The subjects are deprived of food for 4 h and water for 1 h after dosing. All urine and feces specimens excreted within the specified time intervals of 0-240 h and blood specimens sampled at specified time points within 0-168 h after dosing are collected. Phased testing is adopted in this study to determine whether specimen collection may be terminated in advance or the collection time needs to be prolonged based on the test results. If the specimen collection time exceeds that tentatively specified in the protocol, the collection should be extended at an interval of 24 h (urine, feces) or an integer multiple interval of 24 h (blood specimen) until the criteria for termination of specimen collection specified in the protocol are met. Meanwhile, the safety monitoring is continued until the completion date of the specimen collection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Xuhui Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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;
  2. Healthy male subjects between the ages of 18-40 years (inclusive), with normal defecation (1-2 times a day);
  3. Body weight ≥ 50 kg, BMI: 19.0-26.0 kg/m2 (inclusive);
  4. 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);
  5. 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.

Exclusion Criteria:

  1. Allergic constitution or allergic diseases, or known allergies to the ingredients, similar products or excipients of the investigational product;
  2. 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;
  3. 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).
  4. Positive for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus, or treponema pallidum antibody;
  5. Reception of major surgery within 6 months before dosing, or scheduled for a surgery during the study;
  6. History of drug abuse, or use of dope within 3 months before dosing, or positive for urine drug abuse screening;
  7. Mean smoking quantity > 10 cigarettes/d 3 months before dosing;
  8. 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;
  9. Blood loss or blood donation ≥ 400 mL within 3 months before dosing, or blood transfusion within 1 month before dosing;
  10. Use of any drug that inhibits or induces liver drug metabolism enzymes within 1 d before dosing (see Appendix 1 for details);
  11. 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;
  12. Vaccination within 1 month before dosing or scheduled for a vaccination during the study;
  13. 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;
  14. 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;
  15. ther factors that render the subjects unsuitable for participating in this study (determined by the investigators).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]Hemay005
Drug: [14C]Hemay005
Name: [14C]Hemay005 Dose: 60 mg/100 µCi Storage: store at -10℃ to -30 °C, tightly closed and protected from light.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pharmacokinetic (PK) profile of Hemay005
Time Frame: 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.
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 Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ganzhou Hemay Pharmaceutical Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: YanMei Liu, Shanghai Xuhui District Central Hospital
  • Principal Investigator: GangYi Liu, Shanghai Xuhui District Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM005MB1S01/CRC-C2209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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