Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers
Primary Purpose
Alzheimer's Disease, Safety, Tolerability
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD3839
AZD3839 Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease focused on measuring Phase 1, healthy volunteers, double-blind, placebo-controlled, AZD3839, pharmacokinetics, Alzheimer's Disease
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AZD3839
AZD3839 Placebo
Arm Description
Oral Treatment
Oral Treatment
Outcomes
Primary Outcome Measures
Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)
Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2)
Secondary Outcome Measures
Time at which maximum concentration occurs in AZD3839 (Part 1)
Maximum observed concentration of AZD3839 in plasma (Part 1)
Time at which maximum concentration occurs in AZD3839 (Part 2)
Maximum observed concentration of AZD3839 in plasma (Part 2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01348737
Brief Title
Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Safety, Tolerability, Blood Concentration, Healthy Volunteers
Keywords
Phase 1, healthy volunteers, double-blind, placebo-controlled, AZD3839, pharmacokinetics, Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD3839
Arm Type
Experimental
Arm Description
Oral Treatment
Arm Title
AZD3839 Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
AZD3839
Intervention Description
Single Oral Dose
Intervention Type
Drug
Intervention Name(s)
AZD3839 Placebo
Intervention Description
Single Oral Dose
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Darren Wilbraham, MBBS DCPSA
Organizational Affiliation
Quintiles Drug Research Unit at Guy's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Paul Bjornsson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers
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