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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348737
• Other study ID #: D4080C00001
• Secondary ID: 2011-001337-16
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2011
• Last updated: April 5, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Blood Concentration
• Healthy Volunteers
• Safety
• Tolerability

Intervention

Drug:
• AZD3839
Single Oral Dose
• AZD3839 Placebo
Single Oral Dose

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No