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

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ClinicalTrials.gov Identifier: NCT00749333
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : April 30, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AZD8566 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Single Oral Doses of AZD8566 in Healthy Volunteers
Study Start Date : August 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetic profile: concentration of AZD8566 in blood [ Time Frame: Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose ]
  2. 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 :
  1. Pharmacokinetic profile: concentration of AZD8566 in urine [ Time Frame: Samples collected over 48 hours from pre-dose to 48 hours post-dose. ]

Eligibility Criteria

Information from the National Library of Medicine

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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.

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): NCT00749333


Locations
United Kingdom
Research Site
Nottingham, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: William Fahy, MD,MA, MBBS (Hons) Clinical Pharmacology Unit, Queen's Medical Centre, Nottingham, NG7 2UH
More Information

Responsible Party: Harsukh Parmar, Medical Science Director, Respiratory and Inflammation Emerging Product Team, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00749333     History of Changes
Other Study ID Numbers: D1320C00001
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: April 30, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Healthy Volunteer
Safety
Tolerability
AZD8566
study