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LymphomaPhase 1NCT06010680

A Study to Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Volunteers

A Phase 1 study testing [14C]SHR2554 in people with Lymphoma, 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

Evaluate the Mass Balance of [14C]SHR2554 in 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
Lymphoma
What is being tested?
[14C]SHR2554
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
7 Oct 2023to 27 Nov 2023
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

  • Healthy adult males between 18 and 45 years;
  • Total Body weight ≥50 kg, and the body mass index (BMI) of 19 to 26 kg/m2;
  • Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content, and potential adverse reactions;
  • Ability to communicate effectively with the researchers and comply with the trial requirements.

Who cannot join

  • Comprehensive physical examination, vital signs, laboratory tests, 12-lead ECG, chest X-ray (posteroanterior), anal digital examination, abdominal ultrasound with clinically significant abnormalities as determined by the investigator;
  • Resting corrected QT interval (QTcF) >450 ms as obtained from the 12-lead ECG (Note: QTcF interval must be calculated according to Fridericia's method);
  • Positive results in any of the following tests: hepatitis B surface antigen or hepatitis B e antigen, hepatitis C virus antibodies or HIV antigen/antibody combination test (HIV-Ag/Ab);
  • Clinically significant abnormalities in ophthalmic examination (slit lamp, intraocular pressure, and fundus photography);
  • Have taken any clinical trial drug or participated in any clinical trial within 3 months before administration;
  • CYP3A4 inducers or inhibitors were taken within 30 days before administration;
Show all 23Show fewer
  • Have taken any prescription or over-the-counter drugs, vitamin products, health care drugs or traditional Chinese medicines within 14 days before administration;
  • History of any clinically significant medical conditions or conditions that the investigator deems may affect the trial results, including but not limited to cardiovascular, respiratory, endocrine, nervous, digestive, urinary, immune, mental, and metabolic diseases;
  • History of organic heart disease, congestive heart failure, myocardial infarction, angina pectoris, unexplained history of arrhythmia, history of torsades de pointes, history of ventricular tachycardia, atrioventricular conduction block, history of QT prolongation syndrome, or family history of QT prolongation syndrome (confirmed by genetic testing or sudden cardiac death in a close relative at a young age due to cardiac reasons);
  • Those who have undergone major surgery within 6 months before administration or that surgical incision has not completely healed; Major surgery includes, but is not limited to, any surgery that is at significant risk of bleeding, prolongs the period of general anesthesia, or has an incision biopsy or significant traumatic injury;
  • Hemorrhoids or anal diseases accompanied by regular/ongoing rectal bleeding; inability to swallow or a history of gastrointestinal dysfunction such as irritable bowel syndrome, inflammatory bowel disease, or previous gastric resection surgery that may affect drug absorption as determined by the investigator;
  • Allergic predisposition, such as known history of allergy to two or more substances; or deemed by the investigator to be potentially allergic to the investigational drug or its excipients;
  • Habitual constipation or diarrhea;
  • History of alcoholism with alcohol consumption over 14 units per week; and can't abstain from smoking and alcohol during the study;
  • Heavy smoker or habitually use nicotine-containing products;
  • Have a history of drug abuse or have used soft drugs (such as: marijuana) within 3 months before administration or take drugs (such as cocaine, amphetamines, phencyclidine, etc.) within 1 year before administration; or positive urine drug abuse test during screening periods;
  • Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages (more than 8 cups a day, 1 cup = 250 mL) and unable to quit during the study period;
  • Those who cannot tolerate venipuncture or with a history of needle-sickness and blood-sickness;
  • Workers who require long-term exposure to radioactive conditions; or those who have significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥3 other X-ray tests) within 1 year prior to administration or who have participated in radiopharmaceutical labeling tests;
  • Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing;
  • Vaccination within one month prior to screening or planning to be vaccinated during the trial;
  • Intention to conceive or donate sperm during the trial period or within one year after completing the trial, or refusal to strictly adhere to contraceptive measures by the participant and their spouse/partner from the time of signing the informed consent form until one year after completing the trial;
  • Subjects who, in the opinion of the Investigator should not participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215008

Other trials in China

About this study

Official title: Phase I Clinical Trial of Substance Balance of [14C]SHR2554 in Healthy Chinese Subjects

Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Male Volunteers.

Conditions
Lymphoma
Being tested
[14C]SHR2554
Medical subject headings
Lymphoma

What participants receive

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

  • [14C]SHR2554Drug

    Patients will receive single dose of orally [14C]SHR2554 on Day 1.

Study groups in NCT06010680
Study groupRoleWhat they receive
[14C]SHR2554ExperimentalNot described
Receives: Drug: [14C]SHR2554

What is being measured

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

  1. Cumulative recovery and recovery rate of total radioactive substance in urine and feces

    Measured: 0-288 hours

  2. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)

    Measured: 0-240 hours

  3. Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)

    Measured: 0-288 hours

  4. Radioactivity Tmax

    Measured: 0-240 hours

  5. Radioactivity Cmax

    Measured: 0-240 hours

  6. Radioactivity AUC

    Measured: 0-240 hours

  7. Radioactivity t1/2

    Measured: 0-240 hours

  8. Radioactivity CL/F

    Measured: 0-240 hours

  9. Radioactivity Vz/F

    Measured: 0-240 hours

  10. 1Total radioactivity ratio for blood/plasma

    Measured: 0-72 hours

Secondary outcomes (8)

  1. Plasma SHR2554: Tmax

    Measured: 0-240 hours

  2. Plasma SHR2554: Cmax

    Measured: 0-240 hours

  3. Plasma SHR2554: AUC

    Measured: 0-240 hours

  4. Plasma SHR2554: t1/2

    Measured: 0-240 hours

  5. Plasma SHR2554: CL/F

    Measured: 0-240 hours

  6. Plasma SHR2554: Vz/F

    Measured: 0-240 hours

  7. Plasma SHR2554: λz

    Measured: 0-240 hours

  8. AEs and SAEs

    Measured: 0-12 days

Timeline

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

  1. First posted24 Aug 2023
  2. Study start7 Oct 2023
  3. Primary completion27 Nov 2023
  4. Study completion27 Nov 2023

Resources

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
Single oral dose of \[14C\]SHR2554
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010680
Sponsor's protocol ID
SHR2554-I-111
Status last verified
Jan 2024
First submitted
20 Aug 2023
Last updated
1 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]SHR2554 in people with Lymphoma, 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 23 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 1 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?

Cumulative recovery and recovery rate of total radioactive substance in urine and feces (time frame: 0-288 hours). The study lists 10 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 NCT06010680.

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 1 Feb 2024.

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