NCT06896760

A Mass Balance Study of [14C]ABSK011

A Mass Balance Study of [14C]ABSK011 in Healthy Adult Male Chinese Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• 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 \[14C\] 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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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 for 4 hours after taking the medication. Throughout the study, participants received meals provided by the center at approximately the same time each day.

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-11-07
• Completion: 2026-04-07
• First posted: 2025-03-26
• Last updated: 2025-03-26

Locations

1 site across 1 country: China