Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1981

• Registration Number: NCT01058447
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of \[14C\]AZD1981

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-17
• Last Update Posted: 2010-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

Inclusion Criteria

• Provision of signed, written and dated informed consent prior to any study specific procedure
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria

• Exposed to radiation levels above background 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
• History or presence of any clinically significant disease or disorder in the opinion of the investigator
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD1981	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables and Radioactivity	Frequent sampling occasions during study days

Secondary Outcome Measures

Name	Time	Method
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	Frequent sampling occasions during study days