Health VolunteerPhase 1NCT05468645
In Vivo Mass Balance Study of [14C]Hemay005
A Phase 1 study testing [14C]Hemay005 in people with Health Volunteer, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- [14C]Hemay005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2022to 1 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Volunteer
- Being tested
- [14C]Hemay005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]Hemay005Drug
Name: [14C]Hemay005 Dose: 60 mg/100 µCi Storage: store at -10℃ to -30 °C, tightly closed and protected from light.
| Study group | Role | What they receive |
|---|---|---|
| [14C]Hemay005 | Experimental | Not described Receives: Drug: [14C]Hemay005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic (PK) profile of Hemay005
peak concentration (Cmax)
Measured: 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)
Measured: 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-∞)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YanMei Liu, Principal investigator, Shanghai Xuhui District Central HospitalGangYi Liu, Principal investigator, Shanghai Xuhui District Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468645
- Sponsor's protocol ID
- HM005MB1S01/CRC-C2209
- Status last verified
- Feb 2024
- First submitted
- 15 Jun 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Mass Balance Study of a Single Oral Dose of [14C]Hemay005 in Healthy Chinese Male Adults
- ClinicalTrials.gov ID
- NCT05468645
- Acronym / sponsor ID
- HM005MB1S01/CRC-C2209
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| [14C]Hemay005 | Experimental | Drug: [14C]Hemay005 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]Hemay005Name: [14C]Hemay005 Dose: 60 mg/100 µCi Storage: store at -10℃ to -30 °C, tightly closed and protected from light. | Drug | [14C]Hemay005 |
Primary outcome
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)
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)
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-∞)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Health Volunteer
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
Recruiting
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
Healthy Volunteers, Aging, Healthy
Not yet recruiting
BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation
Healthy Subjects, HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YanMei Liu principal investigator
Shanghai Xuhui District Central Hospital
GangYi Liu principal investigator
Shanghai Xuhui District Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]Hemay005 in people with Health Volunteer, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.