Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01348737

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD3839 Oral Treatment	Drug: AZD3839 Single Oral Dose
Placebo Comparator: AZD3839 Placebo Oral Treatment	Drug: AZD3839 Placebo Single Oral Dose

Arm

Intervention/Treatment

Experimental: AZD3839

Oral Treatment

Drug: AZD3839

Single Oral Dose

Placebo Comparator: AZD3839 Placebo

Oral Treatment

Drug: AZD3839 Placebo

Single Oral Dose

Outcome Measures

Primary Outcome Measures

Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1) [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]
Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2) [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 Measures

Time at which maximum concentration occurs in AZD3839 (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)]
Maximum observed concentration of AZD3839 in plasma (Part 1) [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)]
Time at which maximum concentration occurs in AZD3839 (Part 2) [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)]
Maximum observed concentration of AZD3839 in plasma (Part 2) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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