Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers

AstraZeneca6 enrolled

Overview

The aim of this study is to show how the body absorbs, metabolises and excretes the drug \[14C\]AZD0530. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C] AZD0530DRUG

Solution, Oral, once

Eligibility

Sex: MALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Regular Daily Bowel movements * Veins suitable for cannulation or repeated venepuncture Exclusion Criteria: * Presence of any clinically significant illness * Abnormal vital signs * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Locations (1)

Research Site

Alderley Park, Cheshire, United Kingdom

Outcomes

Primary Outcomes

To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530

Time frame: Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose

Secondary Outcomes

To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG

Time frame: From time of consent to last visit

Data from ClinicalTrials.gov

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