A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Study Overview

• Status: Completed
• Conditions: Healthy Men
• Intervention / Treatment: Drug: AZD8329; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 119
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Research Site
  • Uppsala, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures
• Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

• 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 result of the study, or the subject´s ability to participate
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AZD8329; AZD8329 oral solution	Drug: AZD8329; Oral solution, single ascending doses
PLACEBO_COMPARATOR: Placebo; Placebo for AZD8329 oral solution	Drug: Placebo; Oral solution, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.

Secondary Outcome Measures

Outcome Measure	Time Frame
PK samples for AZD8329	Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Wolfgang Kühn, Quintiles AB, Phase I Services, Uppsala, Sweden

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (ESTIMATE): July 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 13, 2010
• Last Update Submitted That Met QC Criteria: September 10, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Safety study; First time in man; AZD8329
• Other Study ID Numbers: D2350C00001; EudraCT No. 2009-010702-11