Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: AZD3480
* Drug: AZD3480


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD3480 iv<br>Single iv infusion AZD3480 | Drug: AZD3480<br>* Iv single dose, 4-hour infusion of 25 mg<br>|
| Experimental: Oral [14C] AZD3480<br>Single oral dose [14C]AZD3480 | Drug: AZD3480<br>* Oral solution single dose of 50 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass balance, AZD3480, Pharmacokinetics, Healthy volunteers