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

NCT ID: NCT04225208

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-03-02

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C]-AZD4205

A single dose of \[14C\]-AZD4205

Group Type: EXPERIMENTAL

[14C]-AZD4205, single 50 mg oral dose administrated on day 1

Intervention Type: DRUG

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 .

Interventions

[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 .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dizal Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Royce Morrison

Role: PRINCIPAL_INVESTIGATOR

Pharmaron CPC

Locations

Pharmaron CPC

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

DZ2019J0002

Identifier Type: -

Identifier Source: org_study_id