Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers

Study Overview
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Brief Summary
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The purpose of the study is to characterise the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD9668.

Official Title
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An Open-Label, Single-Centre, Phase I Study to Assess the Excretion, Metabolism and Plasma Pharmacokinetics Following a Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: [C14]AZD9668


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedure Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg Exclusion Criteria: Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life History or presence of any clinically significant disease or disorder in the opinion of the investigator Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 50 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>[C14]AZD9668 | Drug: [C14]AZD9668<br>* Oral Solution 60 mg Single Dose<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 balance |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 
| Concentration of total radioactivity in blood and plasma |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 
| Plasma concentrations of AZD9668 |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 
| Metabolite profiling and identification in plasma and excreta |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 
| PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR ) |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Adverse events collected prior to treatment and after treatment including follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADME