Trial record 4 of 6 for:    ALZHEIMER DISEASE 14

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

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00777361
First received: October 21, 2008
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: AZD3480
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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. [ 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. ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis. [ Time Frame: From enrollment to follow-up ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777361

Locations
United Kingdom
Research site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Björn Paulsson, MD, PhD AstraZeneca Södertälje, Sweden
Principal Investigator: Tim Mant, Prof Quintiles Drug Research Unit @ Guy´s Hospital
  More Information

No publications provided

Responsible Party: Björn Paulsson, MD, PhD, Medical Science Director Clinical Neuroscience TA, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00777361     History of Changes
Other Study ID Numbers: D3690C00017, EudraCT No.: 2007-005903-16
Study First Received: October 21, 2008
Last Updated: November 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Mass balance
AZD3480, Pharmacokinetics, Healthy volunteers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014