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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 12, 2009
Last updated: April 29, 2009
Last verified: April 2009
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.

Condition Intervention Phase
Drug: AZD8566
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic profile: concentration of AZD8566 in blood [ Time Frame: 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 [ Time Frame: 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:
  • Pharmacokinetic profile: concentration of AZD8566 in urine [ Time Frame: Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10. ]

Estimated Enrollment: 36
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8566
10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee
Placebo Comparator: 2 Drug: Placebo
10ml oral solution administered once a day over 10 days.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00844103

United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
Principal Investigator: Emeline Ramos, MD Clinical Pharmacology Unit
  More Information

Responsible Party: Harsukh Parmar , Medical Science Director, Respiratory and Inflammation Emerging Product Team, AstraZeneca Pharmaceuticals Identifier: NCT00844103     History of Changes
Other Study ID Numbers: D1320C00002
Study First Received: February 12, 2009
Last Updated: April 29, 2009

Keywords provided by AstraZeneca:
AZD8566 processed this record on April 28, 2017