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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00749333
First received: September 5, 2008
Last updated: April 29, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: AZD8566
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 16 defined timepoints pre-dose and post- dose ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8566
solution. Specific dose will be selected by the safety review committee
Placebo Comparator: 2 Drug: Placebo
Single 10ml oral solution.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 5, 2008
Last Updated: April 29, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Healthy Volunteer
Safety
Tolerability
AZD8566
study

ClinicalTrials.gov processed this record on July 24, 2014