Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
MB
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
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedNovember 18, 2010
November 1, 2010
1 year
October 21, 2008
November 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (2)
AZD3480 iv
EXPERIMENTALSingle iv infusion AZD3480
Oral [14C] AZD3480
EXPERIMENTALSingle oral dose \[14C\]AZD3480
Interventions
Eligibility Criteria
You may qualify if:
- Physically healthy volunteers
- Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research site
Macclesfield, Cheshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Björn Paulsson, MD, PhD
AstraZeneca Södertälje, Sweden
- PRINCIPAL INVESTIGATOR
Tim Mant, Prof
Quintiles Drug Research Unit @ Guy´s Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 18, 2010
Record last verified: 2010-11