Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects
Phase 1
Terminated
- Conditions
- Healthy
- Interventions
- Drug: 14C-AZD1236
- Registration Number
- NCT01007929
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of \[14C\] AZD1236 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 4
Inclusion Criteria
- Healthy volunteers
- Non-smokers
Exclusion Criteria
- Subjects who are exposed to radiation exposure as part of their occupation
- Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life
- A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 14C-AZD1236 14C-AZD1236
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile. Concentration of AZD1236 in plasma Before and after dosing Total Radioactivity Before and after dosing
- Secondary Outcome Measures
Name Time Method Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination Before and after dosing
Trial Locations
- Locations (1)
Research Site
🇬🇧Macclesfield, Cheshire, United Kingdom