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

NCT06010680 | Completed Phase 1

• 1 other identifier: SHR2554-I-111
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (10)

• Cumulative recovery and recovery rate of total radioactive substance in urine and feces

  0-288 hours

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

  0-240 hours

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

  0-288 hours

• Radioactivity Tmax

  0-240 hours

• Radioactivity Cmax

  0-240 hours

• Radioactivity AUC

  0-240 hours

• Radioactivity t1/2

  0-240 hours

• Radioactivity CL/F

  0-240 hours

• Radioactivity Vz/F

  0-240 hours

• 1Total radioactivity ratio for blood/plasma

  0-72 hours

Secondary Outcomes (8)

• Plasma SHR2554: Tmax

  0-240 hours

• Plasma SHR2554: Cmax

  0-240 hours

• Plasma SHR2554: AUC

  0-240 hours

• Plasma SHR2554: t1/2

  0-240 hours

• Plasma SHR2554: CL/F

  0-240 hours

Study Arms (1)

[14C]SHR2554

EXPERIMENTAL

Drug: [14C]SHR2554

Interventions

[14C]SHR2554 DRUG

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

[14C]SHR2554

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215008, China

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

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

Model Details: Single oral dose of \[14C\]SHR2554

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: October 7, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

CN (1)