A Mass Balance Study of [14C]ABSK011
ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAbbisko Therapeutics Co, Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
[14C]ABSK011
DrugThe 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 for 4 hours after taking the medication. Throughout the study, participants received meals provided by the center at approximately the same time each day.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: [14C]ABSK011Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
To assess the routes and rates of elimination of ABSK011 and its metabolites after single oral administration of \[14C\]ABSK011 in healthy adult male subjects
Time frame
All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.2
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);
To determine the metabolism and elimination pathways of ABSK011 after single oral administration of \[14C\] ABSK011 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.
Time frame
Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol3
%AUC
To evaluate the pharmacokinetics of ABSK011 and its major metabolites in the urine of healthy adult male subjects after a single oral administration \[14C\] of ABSK011.
Time frame
Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocolSecondary outcomes
1
Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.
To assess the safety and tolerability of a single oral dose of approximately \[14C\] ABSK011 in healthy adult male subjects
Time frame
From signing the ICF until 9 days after the first dosingSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: