Status:
COMPLETED
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Neuroscience
Eligibility:
MALE
50-65 years
Brief Summary
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\]AZD2423 in healthy male volu...
Eligibility Criteria
Inclusion
- Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg
- Regular daily bowel movements (ie, production of at least 1 stool per day)
- Provision of signed and dated, written informed consent prior to any study specific procedures
Exclusion
- Healthy volunteers 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
- Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1)
- History of alcohol abuse or excessive intake of alcohol defined as regular intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01223014
Start Date
November 1 2010
End Date
December 1 2010
Last Update
February 8 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
London, United Kingdom