NCT07537231

A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants.

Detailed description

This is a single-center, single-dose, open-label design study, planned to enroll 6-8 healthy postmenopausal female participants to evaluate the human mass balance of \[14C\]GS1-144. Each participant will receive a single oral dose of approximately 30 mg/100 µCi of \[14C\]GS1-144 oral formulation. During the study, blood, urine, and feces samples will be collected at specified time points/intervals. By measuring the the total radioactivity （TRA ）concentration in whole blood and plasma, and the concentrations of GS1-144, its metabolite M1, and other metabolites (if applicable) in plasma, the PK parameters of TRA of \[14C\]GS1-144 in plasma and whole blood (if applicable) and the PK parameters of GS1-144, its metabolite M1, and other metabolites (if applicable) in plasma will be calculated, and the distribution of TRA between whole blood and plasma will be determined; by measuring the amount of radioactivity in urine and feces, the TRA recovery, radioactivity excretion data, and main excretion pathways will be obtained; through the analysis of the radioactive metabolite profile in plasma, urine, and feces and the structural identification of major metabolites, the metabolic and elimination pathways of GS1-144 in humans will be determined.

Conditions

• Healthy Postmenopausal Women
• Absorption
• Metabolism
• Excretion

Interventions

Type	Name	Description
DRUG	[14C]GS1-144	30 mg/100 µCi \[14C\]GS1-144, taken orally once

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-04-18
• Completion: 2026-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China