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

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

Detailed Description
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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

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-AZD4205<br>A single dose of [14C]-AZD4205 | Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Provide samples for subsequent studies | Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205 | Up to 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Cmax for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting Cmax | Up to 57 days | 
| tmax for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting tmax | Up to 57 days | 
| tlag for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting tlag | Up to 57 days | 
| t1/2 for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting t1/2 | Up to 57 days | 
| λz for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting λz | Up to 57 days | 
| CL/F for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting CL/F | Up to 57 days | 
| Vss/F for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting Vss/F | Up to 57 days | 
| 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 |