Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers - Full Text View

Purpose

The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential

Condition	Intervention	Phase
Alzheimer's Disease Safety Tolerability Blood Concentration Healthy Volunteers	Drug: AZD3839 Drug: AZD3839 Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Biomarkers of AZD3839 Including an Open-label Food Effect Group in Healthy Male and Female Volunteers of Non-childbearing Potential

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1) [ Time Frame: Part 1 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 3) approximately 15 days ] [ Designated as safety issue: Yes ]
Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2) [ Time Frame: Part 2 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 4) approximately 20 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time at which maximum concentration occurs in AZD3839 (Part 1) [ Time Frame: pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3) ] [ Designated as safety issue: No ]
Maximum observed concentration of AZD3839 in plasma (Part 1) [ Time Frame: Part 1 - pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3) ] [ Designated as safety issue: No ]
Time at which maximum concentration occurs in AZD3839 (Part 2) [ Time Frame: Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the Administration. May be taken at the follow-up visit (Visit 4) ] [ Designated as safety issue: No ]
Maximum observed concentration of AZD3839 in plasma (Part 2) [ Time Frame: Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after administration ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	June 2011
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD3839 Oral Treatment	Drug: AZD3839 Single Oral Dose
Placebo Comparator: AZD3839 Placebo Oral Treatment	Drug: AZD3839 Placebo Single Oral Dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive)
Creatinine clearance in the normal range (>80 mL/min estimated according to Cockroft-Gault)
Healthy volunteers should have a serum potassium concentration of ≥3.8 mmol/L at screening (Visit 1) and on admission to the study centre (Day -1)
Clinically normal findings on physical examination in relation to age, as judged by the Investigator

Exclusion Criteria:

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study
History of psychotic disorder amongst first degree relatives
Significant orthostatic reaction at enrolment as judged by the Investigator
Prolonged QTcF greater than 450 msec or shortened QTcF less than 340 msec or family history of long QT syndrome or sudden death
Healthy volunteer is a vegetarian/lactose intolerant (exclusion criterion only applicable for healthy volunteers participating in Part 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348737

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Dr Darren Wilbraham, MBBS DCPSA	Quintiles Drug Research Unit at Guy's Hospital
Study Director:	Dr Paul Bjornsson	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01348737 History of Changes
Other Study ID Numbers:	D4080C00001, 2011-001337-16
Study First Received:	May 4, 2011
Last Updated:	April 5, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:

Phase 1
healthy volunteers
double-blind
placebo-controlled

AZD3839
pharmacokinetics
Alzheimer's Disease

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 May 23, 2013