An Open, Two Period, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following Oral Administration of [14C]-AZD3480 and the Pharmacokinetics of AZD3480 Following Intravenous Administration to Healthy Male Volunteers With Different CYP2D6 Genotype
Overview
- Phase
- Phase 1
- Intervention
- AZD3480
- Conditions
- Alzheimer's Disease
- Sponsor
- AstraZeneca
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
AZD3480 iv
Single iv infusion AZD3480
Intervention: AZD3480
Oral [14C] AZD3480
Single oral dose \[14C\]AZD3480
Intervention: AZD3480
Outcomes
Primary Outcomes
Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)