Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
- Registration Number
- NCT00777361
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 9
Inclusion Criteria
- Physically healthy volunteers
- Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)
Exclusion Criteria
- History of clinically significant diseases or illness.
- Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AZD3480 iv AZD3480 Single iv infusion AZD3480 Oral [14C] AZD3480 AZD3480 Single oral dose \[14C\]AZD3480
- Primary Outcome Measures
Name Time Method Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio. Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours. Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss) 19 and 18 blood samples during 72 and 96 hours after iv (Visit 2) and po dosing (Visit 3) respectively. Urine collection for 72 hours and 168 hours (up to 2 weeks).
- Secondary Outcome Measures
Name Time Method identity of major metabolites in plasma and excreta 4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks). Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis. From enrollment to follow-up
Trial Locations
- Locations (1)
Research site
🇬🇧Macclesfield, Cheshire, United Kingdom