A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)

NCT07454863 | Completed Phase 1 FDA Drug

• 1 other identifier: DZ2025B0003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I study is designed to evaluate absorption, metabolism and excretion (AME) profiles of \[14C\]-DZD8586, to determine the routes, rates of elimination, and mass balance of DZD8586 in healthy adult male participants. Participants will be administered a single oral dose of 50 mg of \[14C\]-DZD8586 (containing radioactive dose \~ 100 μCi) as a suspension.

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Total amount and recovery of the radioactive dose in urine and feces: Ae, Cum Ae, fe and Cum fe

  All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected

• Metabolic profiling of relative abundance of [14C]-DZD8586 and metabolite identification of [14C]-DZD8586 in plasma, urine, and feces

  Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samples at all time points required by the protocol

Secondary Outcomes (28)

• Peak plasma concentration (Cmax) of DZD8586

  up to 504 hours post dose

• Peak plasma concentration (Cmax) of DZ4581

  up to 504 hours post dose

• Peak concentration (Cmax) of total radioactivity concentration equivalents in plasma and whole blood

  Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points defined by the protocol

• Time to Cmax (Tmax) of DZD8586

  up to 504 hours post dose

• Time to Cmax (Tmax) of DZ4581

  up to 504 hours post dose

Study Arms (1)

Carbon-14 labeled DZD8586

EXPERIMENTAL

Single oral administration of Carbon-14 labeled DZD8586 50 mg/100 μCi on empty stomach

Drug: DZD8586

Interventions

DZD8586 DRUG

Carbon-14 labeled DZD8586

Carbon-14 labeled DZD8586

Eligibility Criteria

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

You may qualify if:

• Each participant must meet all criteria below to be included in this study:
• Provision of signed and dated, written informed consent prior to any study-specific procedures.
• Healthy male volunteers aged 18 to 45 years (inclusive) with a body mass index (BMI) between 19 and 26 kg/m2(inclusive) and body weight \> 50 kg.
• The results of physical examination, laboratory tests, chest X-ray (posteroanterior view), electrocardiogram, and/or other auxiliary examinations (including abdominal ultrasound of the liver, gallbladder, pancreas, spleen, and kidneys; ophthalmologic examination; and digital rectal examination) are within normal results during the screening period or abnormal results with no clinical significance judged by the investigator.
• Male volunteers must be willing to use reliable methods of contraception (condom) even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. In addition, volunteers must agree to continue to take similar contraceptive precautions through 12 months after the administration of DZD8586, and avoid procreative sex as well as sperm donation during this period.
• Be willing and able to comply with the study procedures, restrictions, and requirements.

You may not qualify if:

• Each participant who meets any of the criteria below will be excluded from this study:
• Abnormalities in vital signs assessment (including pulse, blood pressure, and tympanic temperature) that persist upon repeat measurement.
• History or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• For gastrointestinal function, the patient who meets the criteria below should be excluded:
• History or clinical manifestation of gastritis, gastrointestinal tract disorder, metabolic disorder, hepatic disorder, or other clinical condition
• Nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week before the screening period.
• Abnormal bowel movements (ie, on average production of less than 1 stool per day) or other gastrointestinal disorder that might affect the intake and absorption of the drug, as judged by the investigator.
• Symptomatic hemorrhoids or perianal disease with regular/active rectal bleeding, irritable bowel syndrome, or inflammatory bowel disease during the screening period.
• History of other risk factors for TdP (such as heart failure, hypokalemia, and family history of long QT syndrome).
• During the screening period, the average resting corrected QTcF interval (QTC) on the ECG is \> 450 msec.
• Major surgery or severe trauma within 4 weeks before the screening, or scheduled surgery during the study period.
• History of hemorrhagic disease (including hemophilia, von Willey-Brandland disease, etc), stroke, or intracranial hemorrhage within 6 months prior to the screening.
• Blood donation (including blood products) or blood loss ≥ 500 mL within 2 months prior to the screening, or receiving blood products within 4 weeks prior to the screening.
• Participants with any malignancy or neoplastic disease history, except those who have undergone excisional surgery of non-melanoma skin cancer over 5 years prior to the screening.
• History of latent or active tuberculosis, or positive screening result.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214062, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Study Officials

• Yiqing Zhao

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 6, 2026
• Study Start: March 16, 2026
• Primary Completion: March 27, 2026
• Study Completion: April 6, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)