Trials Sponsors Conditions Drugs Pricing

Conditions

Central Nervous System (CNS) Metastases EGFR Mutant Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (11)

Total radioactive recovery and cumulative total radioactive recovery in urine and feces at each time interval
Pre-dose up to 312 hours after dosing, or until termination criteria met
Percentage of total radioactivity exposure (%AUC), percentage of parent drug and its metabolites (%Dose), and metabolite identification
Percentage of total radioactivity exposure (%AUC) accounted for by parent drug and its metabolites in plasma. Percentage of administered dose (%Dose) accounted for by parent drug and its metabolites in urine and faeces. Identification of metabolites in plasma, urine, and feces
Pre-dose up to 312 hours after dosing, or until termination criteria met
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)
Pre-dose up to 120 hours after dosing,or until termination criteria met
Time to Peak Concentration (Tmax)
Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)
Pre-dose up to 120 hours after dosing,or until termination criteria met
Area under the plasma concentration versus time curve (AUC)

Secondary Outcomes (9)

Peak Plasma Concentration (Cmax)
Pre-dose up to 120 hours after dosing,or until termination criteria met
Time to Peak Concentration (Tmax)
Pre-dose up to 120 hours after dosing,or until termination criteria met
Area under the plasma concentration versus time curve (AUC)
Pre-dose up to 120 hours after dosing,or until termination criteria met
Elimination Half-Life (t1/2)
Pre-dose up to 120 hours after dosing,or until termination criteria met
Terminal Rate Constant (λz)
Pre-dose up to 120 hours after dosing,or until termination criteria met
+4 more secondary outcomes

Study Arms (1)

Single Dose Zorifertinib Group

EXPERIMENTAL

Drug: [14C]Zorifertinib Oral Formulation

Interventions

[14C]Zorifertinib Oral FormulationDrug

Single oral administration of 200 mg/5 µCi \[¹⁴C\]Zorifertinib in healthy male subjects under fasting condition

Single Dose Zorifertinib Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy Chinese males;
Age at the time of signing the informed consent form: 18-45 years (inclusive);

Sponsors & Collaborators

Alpha Biopharma (Jiangsu) Co., Ltd.
Industrylead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Liyan Miao, Ph.D.
The First Affiliated Hospital of Soochow University
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 2, 2026

Study Start

July 6, 2026

Actual (reported)

Primary Completion

You may not qualify if:

Ancillary Examinations:
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.
Medication History:
Use of any drugs that inhibit or induce the drug-metabolizing enzyme CYP3A4 within 30 days prior to the screening period.
Use of any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (e.g., vitamins, calcium supplements) within 14 days prior to the screening period.
Medical and Surgical History:
History of any clinically serious disease or condition that the investigator believes may affect the trial results, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, urinary, hematologic, immune, psychiatric, or metabolic diseases;
History of dysphagia or any condition that may affect drug absorption, e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, inflammatory bowel disease;
History of organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, ventricular tachycardia, clinically symptomatic AV block, long QT syndrome, or family history of long QT syndrome (evidenced by genetic proof or sudden cardiac death of a close relative at a young age);
Major surgery within 6 months prior to the screening period, or surgical incision not fully healed; Major surgery includes, but is not limited to, any procedure with significant bleeding risk, prolonged general anesthesia, incisional biopsy, or significant traumatic injury;
Allergic constitution, e.g., known history of allergy to two or more substances; Or judged by the investigator as potentially allergic to the investigational drug;
Hemorrhoids or perianal diseases with regular/ongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease.
+14 more criteria

Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (11)

Secondary Outcomes (9)

Study Arms (1)

Single Dose Zorifertinib Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (11)

Secondary Outcomes (9)

Study Arms (1)

Single Dose Zorifertinib Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations