Healthy Adult Male VolunteersPhase 1NCT04260373

Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.

A Phase 1 study testing [14C]SHR4640 in people with Healthy Adult Male Volunteers, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]SHR4640 in Chinese healthy adult male volunteers. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Adult Male Volunteers
What is being tested?: [14C]SHR4640
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 19 Mar 2020to 3 Apr 2020
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Signing the informed consent forms;
Healthy adult males;
Age: 18 Years to 45 Years(Including the boundary value);
Weight: Body mass index(BMI) between 19 and 26 kg/m2(Including the boundary value);

Who cannot join

Persons with abnormal physical examination, routine laboratory examination (blood routine, urine routine, stool routine + occult blood, blood biochemistry, blood coagulation routine, thyroid function), complete set of sex hormones, 12-lead electrocardiogram, X-ray (orthotopic), abdominal b-ultrasound (liver, bile, pancreas, spleen and kidney) and clinical significance;
Hepatitis b surface antigen, e antigen, hepatitis c antibody, HIV antibody and syphilis antibody, any one of these is positive.
Any medication taken within 14 days prior to screening;
Taking any clinical trial drug or participating in any clinical trial of any drug within 3 months prior to the screening period or preparing to participate in any other clinical trial within 1 month after the end of this trial;
Persons with history of organic heart disease, heart failure, myocardial infarction, angina pectoris, cardiac arrhythmias can not be explained, reverse sexual ventricular tachycardia, ventricular tachycardia, lengthened QT syndrome history or have QT syndrome symptoms and family history;
Persons who underwent major surgery within 6 months before the screening period or the surgical incision was not completely healed;Major surgery includes, but is not limited to, any operation with significant risk of bleeding, prolonged general anesthesia, open biopsy or significant traumatic injury;

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A history of any clinical serious illness or disease or condition that the investigator believes may affect the results of the study, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary or blood, immune, mental and metabolic diseases;
Subject with known hypersensitivity or allergy to SHR4640, or any component of SHR4640;
Hemorrhoids or perianal disease with regular/ongoing hematochezia;
Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
Those who have history of alcohol abuse 1 month prior to screening period, or the alcohol breath test results ≥20 mg/dl during screening period；
Subjects who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study;
Subjects who have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive;
Subjects who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test;
Subjects who need long-term exposure to radiation, or who have been exposed to PET-CT or ECT within 3 months prior to study drug administration or who have participated in the labeling test of radiopharmaceuticals;
Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial;
Subjects who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Phase I Mass Balance and Biotransformation Study of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]SHR4640 in Chinese healthy adult male volunteers.

Conditions: Healthy Adult Male Volunteers
Being tested: [14C]SHR4640

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]SHR4640Drug
Patients will receive single dose of orally [14C]SHR4640 on Day 1.

Study groups in NCT04260373
Study group	Role	What they receive
[14C]SHR4640	Experimental	Patients will receive single dose of [14C]SHR4640 (Suspension, 10mg/80μCi). Receives: Drug: [14C]SHR4640

What is being measured

The primary outcome is the main question the study is designed to answer.

Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR4640 in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter.
The percentage of radioactive dose of [14C] radiolabelled SHR4640 recovered in urine, faeces and in total, up to Day 10 (approx).
Measured: Up to 10 days (approx) from the start of administration.
Quantitive analysis of the concentrations of SHR4640 in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
The concentrations of SHR4640 in plasma up to Day 10.
Measured: Up to 10 days (approx) from the start of administration.
Identification of the main metabolite and biotransformation pathway of SHR4640 and investigation of metabolite in plasma by LC-HR MS.
Proportion of different metabolites.
Measured: Up to 10 days (approx) from the start of administration.

Secondary outcomes (1)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events.
Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.
Measured: Up to 10 days (approx) from the start of administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 20203 Apr 2020

First posted7 Feb 2020
Study start19 Mar 2020
Primary completion3 Apr 2020
Study completion3 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Adult Male VolunteersStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04260373
Sponsor's protocol ID: SHR4640-106
Status last verified: Apr 2020
First submitted: 20 Jan 2020
Last updated: 14 Apr 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Adult Male Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Mass Balance and Biotransformation Study of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.
ClinicalTrials.gov ID: NCT04260373
Acronym / sponsor ID: SHR4640-106
Conditions: Healthy Adult Male Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Mar 2020 (actual)
Primary completion: 3 Apr 2020 (actual)
Study completion: 3 Apr 2020 (actual)
First posted: 7 Feb 2020 (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.

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]SHR4640 in Chinese healthy adult male volunteers.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C]SHR4640	Experimental	Drug: [14C]SHR4640Patients will receive single dose of [14C]SHR4640 (Suspension, 10mg/80μCi).

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Signing the informed consent forms;
Healthy adult males;
Age: 18 Years to 45 Years(Including the boundary value);
Weight: Body mass index(BMI) between 19 and 26 kg/m2(Including the boundary value);

Key exclusion criteria (17 listed)

Persons with abnormal physical examination, routine laboratory examination (blood routine, urine routine, stool routine + occult blood, blood biochemistry, blood coagulation routine, thyroid function), complete set of sex hormones, 12-lead electrocardiogram, X-ray (orthotopic), abdominal b-ultrasound (liver, bile, pancreas, spleen and kidney) and clinical significance;
Hepatitis b surface antigen, e antigen, hepatitis c antibody, HIV antibody and syphilis antibody, any one of these is positive.
Any medication taken within 14 days prior to screening;
Taking any clinical trial drug or participating in any clinical trial of any drug within 3 months prior to the screening period or preparing to participate in any other clinical trial within 1 month after the end of this trial;
Persons with history of organic heart disease, heart failure, myocardial infarction, angina pectoris, cardiac arrhythmias can not be explained, reverse sexual ventricular tachycardia, ventricular tachycardia, lengthened QT syndrome history or have QT syndrome symptoms and family history;

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]SHR4640Patients will receive single dose of orally [14C]SHR4640 on Day 1.	Drug	[14C]SHR4640

Primary outcome

Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR4640 in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter.
Time frame: Up to 10 days (approx) from the start of administration.
The percentage of radioactive dose of [14C] radiolabelled SHR4640 recovered in urine, faeces and in total, up to Day 10 (approx).
Quantitive analysis of the concentrations of SHR4640 in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
Time frame: Up to 10 days (approx) from the start of administration.
The concentrations of SHR4640 in plasma up to Day 10.
Identification of the main metabolite and biotransformation pathway of SHR4640 and investigation of metabolite in plasma by LC-HR MS.
Time frame: Up to 10 days (approx) from the start of administration.
Proportion of different metabolites.

1 secondary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events.
Time frame: Up to 10 days (approx) from the start of administration.

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 14 Apr 2020.

Related trials for Healthy Adult Male Volunteers

RecruitingPhase 1/2
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Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
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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.

The record lists no contact. Use the official record to reach the sponsor.

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]SHR4640 in people with Healthy Adult Male Volunteers, run by Jiangsu HengRui Medicine 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 4 inclusion and 17 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 14 Apr 2020. 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?

Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR4640 in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter. (time frame: Up to 10 days (approx) from the start of administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260373.

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 14 Apr 2020.