Healthy
Conditions
Keywords
Healthy Volunteers, ADME
Brief summary
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.
Interventions
DRUG[14C] AZD0530
Solution, Oral, once
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530 | Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG | From time of consent to last visit |
Countries
United Kingdom
Outcome results
None listed