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Clinical Trials/NCT01058447
NCT01058447
Completed
Phase 1

An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

AstraZeneca0 sites4 target enrollmentFebruary 2010
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ConditionsHealthy
InterventionsAZD1981
DrugsAZD1981

Overview

Phase
Phase 1
Intervention
AZD1981
Conditions
Healthy
Sponsor
AstraZeneca
Enrollment
4
Primary Endpoint
Pharmacokinetic variables and Radioactivity
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
March 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Eligibility Criteria

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

Arms & Interventions

1

Intervention: AZD1981

Outcomes

Primary Outcomes

Pharmacokinetic variables and Radioactivity

Time Frame: Frequent sampling occasions during study days

Secondary Outcomes

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

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