NCT06233916

Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

* To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of \[14C\] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans; * To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways; * To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Detailed description

Primary Objectives: * To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of \[14C\] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans; * To obtain radioactive metabolite profiles of human plasma, urine and feces after a single oral dose of \[14C\] D-1553 in healthy subjects, identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways; * To quantitatively analyze the TRA in whole blood and plasma after a single oral dose of \[14C\] D-1553 in subjects, and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA. Secondary Objectives: * To observe the safety of a single oral dose of \[14C\] D-1553 in healthy subjects; * To quantitatively analyze the concentration of D-1553 and its metabolites (if applicable) in plasma using the validated LC-MS (liquid chromatography-mass spectrometry)/MS method and obtain the pharmacokinetic (PK) parameters of D-1553 and its metabolites (if applicable) in plasma.

Conditions

• Mass Balance Study

Interventions

Type	Name	Description
DRUG	[14C] D-1553	\[14C\] D-1553 (approximately 400 mg/80 μCi)

Timeline

• Start date: 2023-12-08
• Primary completion: 2024-01-03
• Completion: 2024-01-10
• First posted: 2024-01-31
• Last updated: 2024-02-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study