Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

Healthy Volunteers Clinical Trial

— SAD  

Official title:

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940212
• Other study ID #: D2600C00001
• Secondary ID: EudraCT 2009-010
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2009
• Last updated: December 8, 2010
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures

• Have a body mass index (BMI) between =18 and =30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg

• Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study

• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

• Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD2423
oral, single administration
• Placebo
oral administration and single dose

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.		3 day residential period plus 7-10 days follow up	Yes
Secondary	To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423.		3 day residential period plus 7-10 days follow up	No