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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777361
Recruitment Status : Terminated
First Posted : October 22, 2008
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: AZD3480 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : October 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD3480 iv
Single iv infusion AZD3480
 Drug: AZD3480
Iv single dose, 4-hour infusion of 25 mg
Experimental: Oral [14C] AZD3480
Single oral dose [14C]AZD3480
 Drug: AZD3480
Oral solution single dose of 50 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
  2. 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 Outcome Measures :
  1. 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). ]
  2. Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis. [ Time Frame: From enrollment to follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777361


Locations
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United Kingdom
Research site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Björn Paulsson, MD, PhD AstraZeneca Södertälje, Sweden
Principal Investigator: Tim Mant, Prof Quintiles Drug Research Unit @ Guy´s Hospital
More Information
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Responsible Party: Björn Paulsson, MD, PhD, Medical Science Director Clinical Neuroscience TA, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00777361    
Other Study ID Numbers: D3690C00017
EudraCT No.: 2007-005903-16
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010
Keywords provided by AstraZeneca:
Mass balance
AZD3480, Pharmacokinetics, Healthy volunteers
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders