Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
- Registration Number
- NCT00832169
- 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 AZD1386 in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
- Healthy volunteer must have regular bowel movements (at least once daily)
Exclusion Criteria
- History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
- A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
- Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD1386 -
- Primary Outcome Measures
Name Time Method Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386 Until >90% of predicted total radioactivity has been recovered Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h
- Secondary Outcome Measures
Name Time Method AZD1386 metabolites in plasma+excreta if feasable Predose, 1h, 4h, 8h 24h Safety + tolerability of AZD1386 Predose, 2h, 6h, 12h, 24h, 48h, 168h
Trial Locations
- Locations (1)
Research Site
🇬🇧Macclesfield, Cheshire, United Kingdom