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

Phase 1
Completed
Conditions
Healthy
Interventions
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

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
GroupInterventionDescription
1AZD1981-
Primary Outcome Measures
NameTimeMethod
Pharmacokinetic variables and RadioactivityFrequent sampling occasions during study days
Secondary Outcome Measures
NameTimeMethod
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)Frequent sampling occasions during study days
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