NCT06186583

A Mass Balance Study of [14C]ABSK021

A Mass Balance Study of [14C]ABSK021 in Healthy Adult Male Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of \[14C\] ABSK021 in healthy adult male subjects. The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects.

Detailed description

Subjects will be screened within 14 days before dose administration (D-14 to D-3), and will be admitted to the trial ward two days before dose administration (D-2). On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of \[14C\] ABSK021 in the fasted state. All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected. Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples (if there are multiple blank samples, the most recent blank sample before dosing will be selected for analysis).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Pimicotinib（ABSK021）	A standard meal should be given to the subjects in the evening before dosing. Then, the subjects should fast for at least 10 hours. Water is not prohibited overnight. The next morning, the subjects should administer study drug in fasted state with warm water. The total volume of warm water and suspension is approximately 240 mL. Water is prohibited from 1 hour before dosing to 1 hour after dosing. No food is allowed within 4 hours after dosing. During the study, subjects will receive standardized meals at approximately the same time each day.

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-05-30
• Completion: 2024-07-30
• First posted: 2024-01-02
• Last updated: 2024-08-12

Locations

1 site across 1 country: China