A Mass Balance Study of [14C]ABSK011
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [14C]ABSK011.
- Who it may be relevant to
- Registry conditions: Healthy Subjects. Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Mass Balance Study of [14C]ABSK011 in Healthy Adult Male Chinese Participants
Overview
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of \[14C\] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.
Detailed description
Participants will be screened no more than 14 days before the dose (D-14 through D-3) and admitted to the clinical trial unit 2 days before the dose (D-2). Participants will receive a single oral administration of approximately 200 mg/120 µCi \[14C\]ABSK-011 suspension after a low-fat breakfast on day 1 morning.
Urine and stool samples will be collected from participants before and at specified intervals between 0 and 192 hours after taking the drug and blood samples will be collected at specified time points between 0 and 120 hours before and after taking the drug.
Interventions
- Drug [14C]ABSK011
The standard meal was taken the night before administration, and the patient was fasted for at least 10 h without drinking water overnight. The next morning, eat a low-fat meal, finish the meal within 30 minutes, and take the test drug with warm water 30 minutes (±5 minutes) after the beginning of the meal. The total volume of warm water and suspension liquid is about 240 mL. Except for meals and administration, no water was allowed 1 hour before and 1 hour after medication. No food is allowed f
Primary outcome measures
- Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces) [Time frame: All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.]
- Percentage of each metabolite in urine and feces relative to the administered dose (% administered dose), or percentage of metabolites in plasma relative to total exposure AUC (% AUC); [Time frame: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol]
- %AUC [Time frame: Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol]
Secondary outcome measures (1)
- Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc. [Time frame: From signing the ICF until 9 days after the first dosing]
Eligibility criteria
Inclusion criteria
- Participants who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
- Healthy male participants aged 18 to 45 years (including 18 and 45 years) at screening;
- Weight ≥ 50 kg, body mass index (BMI) between 19 and 26 (including 19 and 26), BMI = weight (kg)/height (m) \^2;
- Participants must have regular defecation in the past three months;
- Male participants of childbearing potential must agree to use effective contraceptive methods during the study and within 6 months after administration of study drug . Male subjects must agree to not donate sperm during this period.
Exclusion criteria
- Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
- Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
- The baseline of heart rate corrected QT, QTcF interval prolongs ≥450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
- Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;
- Known history of allergy to any drug or food;
- Participants who have participated in drug trials within 3 months before dosing.
- Participants who have participated in this study or any other study related to ABSK011, and have previously exposed to ABSK011;
- Known history of drug abuse or tested positive in drug abuse screening;
- Participants with any other factors that may influence the participation in the study, which may affect the subject's compliance with the protocol, interfere with the interpretation of the study results, or expose the subject to risk, as judged by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing GoBroad Hospital — Beijing
Identifiers
NCT: NCT06896760 · ABSK-011-103