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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225208
• Other study ID #: DZ2019J0002
• Status: Completed
• Phase: Phase 1
• Start date: January 6, 2020
• Est. completion date: March 2, 2020

Study information

• Verified date: December 2019
• Source: Dizal Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1. Healthy male subjects aged 18 to 65, who must be willing to use reliable methods of contraception, even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil.

• 2. In addition, subjects must agree to continue to take similar contraceptive precautions until 6 months after administration of AZD4205 and avoid procreative sex as well as sperm donation for 6 months after administration of AZD4205.

Exclusion Criteria:

• 1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at screening or baseline in the opinion of the investigator.

• 2. Subjects who may have been exposed to radiation for therapeutic or diagnostic reasons at levels above background (e.g,, through X-ray examination other than dental X-rays or plain X-rays of thorax or bony skeleton) of > 5 mSv in last year, > 10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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 .

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Dizal Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events, and serious adverse events	To assess the safety and tolerability of a single dose of AZD4205 in healthy adult male subjects.	Up to 57 days
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage	To evaluate the percentage of radioactive dose of [14C] radiolabelled AZD4205 recovered in urine, feces, and in total	Up to 57 days
Primary	Provide samples for subsequent studies	Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205	Up to 57 days
Secondary	AUC(0-inf) for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting AUC(0-inf)	Up to 57 days
Secondary	AUC(0-t) for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting AUC(0-t)	Up to 57 days
Secondary	Cmax for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting Cmax	Up to 57 days
Secondary	tmax for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting tmax	Up to 57 days
Secondary	tlag for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting tlag	Up to 57 days
Secondary	t1/2 for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting t1/2	Up to 57 days
Secondary	?z for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting ?z	Up to 57 days
Secondary	CL/F for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting CL/F	Up to 57 days
Secondary	Vss/F for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting Vss/F	Up to 57 days
Secondary	Distribution of total radioactivity in blood	To compare disposition of drug-related total radioactivity in whole blood to that in plasma	Up to 57 days