AZD5423 Multiple Ascending Dose Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD5423; Drug: Placebo

• Registration Number: NCT01037504
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-20
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Study Start: 2010-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

• Any clinically significant disease or disorder
• Any clinically significant abnormalities at screening examination
• Use of any prescribed or non-prescribed medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	AZD5423	Drug: AZD5423
B	Placebo	Drug: Placebo

Primary Outcome Measures

Name	Time	Method
Safety variables: adverse events	Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics profile: concentration of AZD5423 in plasma	Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.
Investigation of PD effects	Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London Bridge, Greater London, United Kingdom