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

Phase 1TerminatedNCT00777361

AstraZeneca9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

AZD3480DRUG

Iv single dose, 4-hour infusion of 25 mg

AZD3480DRUG

Oral solution single dose of 50 mg

Eligibility

Sex: MALEMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research site

Macclesfield, Cheshire, United Kingdom

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

Time frame: 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.

Time frame: From enrollment to follow-up

Data from ClinicalTrials.gov

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