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

Alzheimer's Disease Clinical Trial

— MB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00777361
• Other study ID #: D3690C00017
• Secondary ID: EudraCT No.: 200
• Status: Terminated
• Phase: Phase 1
• First received: October 21, 2008
• Last updated: November 17, 2010
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AZD3480
Iv single dose, 4-hour infusion of 25 mg
• AZD3480
Oral solution single dose of 50 mg

Locations

Country	Name	City	State
United Kingdom	Research site	Macclesfield	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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).	No
Secondary	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).	No
Secondary	Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.		From enrollment to follow-up	No