A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15) (NCT07454863) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)
China6 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Total amount and recovery of the radioactive dose in urine and feces: Ae, Cum Ae, fe and Cum fe
Timeframe: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected
2
Metabolic profiling of relative abundance of [14C]-DZD8586 and metabolite identification of [14C]-DZD8586 in plasma, urine, and feces
Timeframe: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samples at all time points required by the protocol
. 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.