Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.

A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AZD8566 in Healthy Volunteers

The purpose of this study is to determine how well tolerated and safe AZD8566 is at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: AZD8566; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of written informed consent.
• Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
• Females who are permanently or surgically sterile or postmenopausal.

Exclusion Criteria:

• Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
• History of any convulsions or seizures
• History of infection or at risk of infection due to recent surgery or trauma
• History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD8566; solution. Specific dose will be selected by the safety review committee
Placebo Comparator: 2	Drug: Placebo; Single 10ml oral solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events	Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
Pharmacokinetic profile: concentration of AZD8566 in blood	Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic profile: concentration of AZD8566 in urine	Samples collected over 48 hours from pre-dose to 48 hours post-dose.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: William Fahy, MD,MA, MBBS (Hons), Clinical Pharmacology Unit, Queen's Medical Centre, Nottingham, NG7 2UH

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): April 30, 2009
• Last Update Submitted That Met QC Criteria: April 29, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Safety; Healthy Volunteer; Tolerability; study; AZD8566
• Other Study ID Numbers: D1320C00001