Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
Phase 1
Completed
- Conditions
- Pain
- Registration Number
- NCT00829088
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Provision of signed informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.
Exclusion Criteria
- History of somatic disease/condition, which may interfere with the objectives of the study.
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
- Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examinations).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066 Until >90% of predicted total radioactivity has been recovered Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma Sampling at defined timepoints during residential period from pre-dose until 168h post-dose. Metabolite profile in plasma and excreta Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.
- Secondary Outcome Measures
Name Time Method AZD2066 metabolites in plasma+excreta if feasable Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.
Trial Locations
- Locations (1)
Research Site
🇬🇧Cheshire, United Kingdom