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A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051505
First Posted: January 18, 2010
Last Update Posted: June 25, 2015
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 (Responsible Party):
AstraZeneca
  Purpose

The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects.

AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.


Condition Intervention Phase
Healthy Drug: AZD5069 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Administration of Multiple Ascending Doses for 8 Days in Healthy Male or Female Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry [ Time Frame: Baselines assessments at Visit 1 (enrolment) or pre-dose on Day 1 with assessments during Visit 2 at protocol defined time-points post-dose until 96hr post final dose. Follow up assessments at Visit 3 ]

Secondary Outcome Measures:
  • Pharmacokinetic profile: concentration of AZD5069 in blood [ Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose ]
  • Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood [ Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose ]
  • Measurement of the effect of AZD5069 on blood cells [ Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose ]

Enrollment: 8
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD5069
oral suspension dose of AZD5069. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
Placebo Comparator: 2 Drug: Placebo
oral suspension dose of matched placebo. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7

  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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
  • Healthy male or female (of non child bearing potential)volunteers with suitable veins for cannulation or repeated venepuncture

Exclusion Criteria:

  • Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate
  • Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
  • Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
  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): NCT01051505


Locations
United Kingdom
Research Site
London Bridge, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Quintiles, Inc.
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01051505     History of Changes
Other Study ID Numbers: D3550C00007
First Submitted: January 11, 2010
First Posted: January 18, 2010
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by AstraZeneca:
Phase I
multiple ascending dose
Safety
Tolerability
Healthy Volunteer