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

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

The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, 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: Pharmacokinetics
• Intervention / Treatment: Drug: AZD8566; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Macclesfield, Cheshire, 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 and males.

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
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; 10ml oral solution administered once a day over 10 days.
EXPERIMENTAL: 1	Drug: AZD8566; 10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic profile: concentration of AZD8566 in blood	Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10
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.

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 on Day 1 and Day 10.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Emeline Ramos, MD, Clinical Pharmacology Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: February 12, 2009
• First Submitted That Met QC Criteria: February 12, 2009
• First Posted (ESTIMATE): February 13, 2009

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; Tolerability; Volunteer; AZD8566
• Other Study ID Numbers: D1320C00002