Status:

COMPLETED

Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

Lead Sponsor:

AstraZeneca

Conditions:

Rheumatoid Arthritis

Eligibility:

MALE

50+ years

Phase:

PHASE1

Brief Summary

The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Eligibility Criteria

Inclusion

  • Body Mass index (BMI) 18-30 kg/m2, inclusive.
  • Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology \& urinalysis, as judged by the investigator

Exclusion

  • Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) 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
  • Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
  • Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2008

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT00711074

Start Date

June 1 2008

End Date

July 1 2008

Last Update

April 9 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Research Site

Macclesfield, Cheshire, United Kingdom