Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAlpha Biopharma (Jiangsu) Co., Ltd.
About this trial
This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg/5 µCi dose of \[14C\]Zorifertinib in healthy Chinese adult male participants. The study includes a screening period (Day -14 to Day -1) and a dosing and observation period (Day 1 to Day 14). Blood, urine, and feces samples will be collected to measure radioactivity, drug concentrations, and metabolites. Safety will be assessed by adverse events, vital signs, laboratory tests, 12-lead ECG, and ophthalmic examinations. The target total radioactivity recovery is ≥90% of the administered dose.
Eligibility criteria
Qualifiers
Healthy Chinese males;
Age at the time of signing the informed consent form: 18-45 years (inclusive);
Body mass index (BMI) ranging from 19-26 kg/m2 (inclusive), with a body weight of no less than 50 kg;
Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;
Disqualifiers
Abnormal findings from comprehensive physical examination, vital signs, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis, routine stool + occult blood, thyroid function), 12-lead ECG, chest X-ray (posteroanterior view), abdominal ultrasound, digital rectal examination, etc., that are judged by the investigator as clinically significant.
Resting corrected QT interval (Fridericia correction, QTcF = QT/RR1/3) obtained from 12-lead ECG >450 ms in males, or other abnormalities judged by the investigator as clinically significant.
Positive result for any of the following: hepatitis B surface antigen or hepatitis B e antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab).
Abnormal findings from ophthalmic examination (slit lamp, intraocular pressure, fundus photography) that are clinically significant.
Trial design
Treatments tested in this trial
- [14C]Zorifertinib Oral Formulation
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov