NCT04225208

Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers

A Phase I, Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\]-AZD4205.

Detailed description

Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME properties of AZD4205 by analyzing blood, urine and feces collected during the study

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-AZD4205, single 50 mg oral dose administrated on day 1	Each subject will receive 50 mg AZD4205 oral solution (free base equivalent) containing a nominal dose of 15 µCi \[14C\]- radiolabelled AZD4205 as a single administration .

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2020-01-13
• Last updated: 2020-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study