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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD2423; Drug: Placebo

• Registration Number: NCT00940212
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	AZD2423	AZD2423
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany