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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-29
• Status Verified: 2009-11
• Study Completion: 2009-11
• Study First Submitted QC: 2009-11-04
• Study First Posted: 2009-11-05
• Last Update Submitted: 2009-11-19
• Last Update Posted: 2009-11-20

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