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

NCT01058447 — Phase 1, Completed, 4 participants, AstraZeneca

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

RegistryNCT01058447, acronym ADME
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none, basic science
Enrollment4 (Actual)
SponsorAstraZeneca (Industry)
ConditionsHealthy
InterventionsAZD1981 (Drug)
Datesstart 2010-02-01, primary completion 2010-03-01, completion 2010-03-01, first posted 2010-01-28, last updated 2010-11-18

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
1ExperimentalDrug: AZD1981
  • AZD1981 (Drug): Oral tablet, 250 mg, single dose

+Outcome measures

Primary outcomes

  • Pharmacokinetic variables and Radioactivity [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]

+Eligibility

Sex: Male, ages: 50 Years to 65 Years, accepts healthy volunteers

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

+Investigators

  • Eva S Pettersson, Study director, AstraZeneca R&D, Lund, Sweden
  • Tim Mant, Professor, Principal investigator, Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom