NCT05159895

Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects

A Phase 1, Single-Center, Nonrandomized, Open-label Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open-label, ADME study with single oral administration of \[14C\]-DZD9008 in healthy subjects.

Detailed description

Phase 1 study to evaluate the excretion of DZD9008 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\]-DZD9008 in healthy male subjects. The purpose of this study is to investigate ADME properties of DZD9008 by analyzing blood, urine and feces samples collected during the study

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-DZD9008	Each subject will receive a total of 100 mg DZD9008 oral suspension containing approximately 1 μCi of \[14C\] as a single administration

Timeline

• Start date: 2021-09-24
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2021-12-16
• Last updated: 2022-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study