Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206, China
Location contact
Quankun Zhuang, Doctor
CONTACT
Quankun Zhuang, Doctor
PRINCIPAL_INVESTIGATOR
Xuemei Liu, Doctor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06896760
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.
Trial opening soon.
Get Notified18 year–45 year
Male
Interventional
Phase 1
Beijing, Beijing Municipality, 102206, China
Quankun Zhuang, Doctor
CONTACT
Quankun Zhuang, Doctor
PRINCIPAL_INVESTIGATOR
Xuemei Liu, Doctor
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 for 4 hours after taking the medication. Throughout the study, participants received meals provided by the center at approximately the same time each day.
Time frame: All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.
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: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
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 all samples at all time points required by the protocol
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: From signing the ICF until 9 days after the first dosing
To assess the safety and tolerability of a single oral dose of approximately [14C] ABSK011 in healthy adult male subjects
Contact information is provided by the study sponsor or research team.
Abbisko Therapeutics Co, Ltd
Industry
A Mass Balance Study of [14C]ABSK011 in Healthy Adult Male Chinese Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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