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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844103
First Posted: February 13, 2009
Last Update Posted: April 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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
Pharmacokinetics Drug: AZD8566 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844103


Locations
United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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
ClinicalTrials.gov Identifier: NCT00844103     History of Changes
Other Study ID Numbers: D1320C00002
First Submitted: February 12, 2009
First Posted: February 13, 2009
Last Update Posted: April 30, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Volunteer
Safety
Tolerability
AZD8566