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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

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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

NCT ID

NCT01348737

First Posted

May 4, 2011

Last Updated

April 5, 2012

Sponsor

AstraZeneca

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

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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