Back to resultsStudy of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers (MB)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD3480
AZD3480
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease focused on measuring Mass balance, AZD3480, Pharmacokinetics, Healthy volunteers
Eligibility 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.
Sites / Locations
- Research site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AZD3480 iv
Oral [14C] AZD3480
Arm Description
Single iv infusion AZD3480
Single oral dose [14C]AZD3480
Outcomes
Primary Outcome Measures
Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.
Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss)
Secondary Outcome Measures
identity of major metabolites in plasma and excreta
Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00777361
Brief Title
Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Mass balance, AZD3480, Pharmacokinetics, Healthy volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD3480 iv
Arm Type
Experimental
Arm Description
Single iv infusion AZD3480
Arm Title
Oral [14C] AZD3480
Arm Type
Experimental
Arm Description
Single oral dose [14C]AZD3480
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
Iv single dose, 4-hour infusion of 25 mg
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
Oral solution single dose of 50 mg
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
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).
Title
Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.
Time Frame
From enrollment to follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Paulsson, MD, PhD
Organizational Affiliation
AstraZeneca Södertälje, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tim Mant, Prof
Organizational Affiliation
Quintiles Drug Research Unit @ Guy´s Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research site
City
Macclesfield
State/Province
Cheshire
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
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