AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

Study Overview
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Brief Summary
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To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.

Official Title
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A Phase I, Single-centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C-labelled AZD1722 in Healthy Male Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AZD1722


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged ≥50 years Regular daily bowel movements. Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg. Exclusion Criteria: History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study. History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs. Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre. Volunteers exposed to radiation levels above background (eg, via X-ray examination) 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. Participation in a previously radiolabelled study within the last 5 years

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1722<br>Single oral dose 15 mg of [14C]AZD1722 | Drug: AZD1722<br>* Single oral dose 15 mg of [14C]AZD1722<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 feces |  | Day 1: Pre-dose and up to 168 hours post-dose | 
| Total percentage of radioactive dose recovered from both urine and feces |  | Day 1: Pre-dose and up to 168 hours post-dose | 
| Concentration of total radioactivity in blood and plasma samples |  | Timeframe: Day 1: Predose and up to 120 hours | 
| Concentration of AZD1722 in plasma samples |  | Timeframe: Day 1: Predose and up to 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests) |  | up to 50 days |